MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71339550

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Dislocation (2374)

Event Date 11/10/2020

Event Type  Injury  

Event Description

It was reported that, after a tha had been performed on (b)(6) 2020, the patient experienced a disassociation of the 0 deg xlpe acet lnr 32mm x 50mm originally implanted.This adverse event was solved by replacing the liner on (b)(6) 2020 with a smith and nephew 32mm x 50mm 0 degree liner.Patient is currently stable.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint form, this patient experienced a disassociation a few weeks post implantation of an r3 0 deg xlpe acet lnr 32mm x 50mm.However, without the requested relevant clinical information a thorough clinical investigation cannot be rendered, nor can the root cause of the reported disassociation cannot be determined.Per subsequent e-mail, the surgeon reported he does not know what the patient was at the time of the disassociation.In addition, it was reported, the surgeon, believes the patient was compliant but did not report any issues even after having said afterward that she felt a grinding situation.Based on information provided, this adverse event was solved by the surgeon replacing the liner with a smith and nephew 32mm x 50mm 0-degree liner.Since it was reported the patient is in a stable condition, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Event Description

It was reported that, approximately a month after a tha had been performed on the patient's right hip on (b)(6) 2020, the patient experienced a sudden onset of a grinding sensation in her right hip.Further radiographs revealed what appeared to be a spun out of approximately 90 degrees anteriorly of the r3 0 deg xlpe acet lnr 32mm x 50mm originally implanted.This adverse event was treated with a revision surgery performed on (b)(6) 2020, in which the r3 0 deg xlpe acet lnr 32mm x 50mm and oxinium fem hd 12/14 32mm +0 were replaced.Intraoperatively, the oxinium fem hd 12/14 32mm +0 was noticed to have significant surface wear, since it was articulating directly with the titanium shell.Upon removal and inspection of the r3 0 deg xlpe acet lnr 32mm x 50mm, a single broken off piece was noticed to be retained in the acetabular cup.The patient recovered uneventfully and transferred stable to pacu.Due to revision surgery, the patient currently experiences some level of pain and decreased range of motion daily.Patient is currently stable.

Manufacturer Narrative

Updated due to new information received.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, based on the documentation provided, the root cause of the ¿broken and dislodged¿ poly liner, reported symptoms, and subsequent revision could not be definitively concluded.However, unable to rule out the reported ¿pop¿ while transferring on/off the hospital toilet ¿later that day¿ of the post-primary right tha as a contributing factor.The patient also reported sudden knee/leg buckling just days prior to complaints of loud squeaky/creaking/grinding noises after a ¿long walk¿ approximately 3 weeks post-op.The liner alignment in relation to the acetabular shell in the provided intra-op image could not be confirmed as comparison imaging from the immediate post-op phase and/or following the patient reported ¿pop¿while transferring on/off toilet in hospital room¿ was not provided.The reported ¿failed liner locking mechanism¿ could not be confirmed as the explanted liner did not return for evaluation.The patient impact beyond the reported symptoms and events could not be determined, although pt notes (5/05/2021) indicated improvement of trochanteric/psoas bursitis post injection and improved back/hip pain.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to injury, patient anatomy, abnormal loading of limb or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

Manufacturer Narrative

Additional information added: d10.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the documentation provided, the root cause of the ¿broken and dislodged¿ poly liner, reported symptoms, and subsequent revision could not be definitively concluded.However, unable to rule out the reported ¿pop¿ while transferring on/off the hospital toilet ¿later that day¿ of the post-primary right tha as a contributing factor.The patient also reported sudden knee/leg buckling just days prior to complaints of loud squeaky/creaking/grinding noises after a ¿long walk¿ approximately 3 weeks post-op.The liner alignment in relation to the acetabular shell in the provided intra-op image could not be confirmed as comparison imaging from the immediate post-op phase and/or following the patient reported ¿pop¿while transferring on/off toilet in hospital room¿ was not provided.The reported ¿failed liner locking mechanism¿ (and/or the successful locking of the primary liner) could not be confirmed as the explanted liner did not return for evaluation.The patient impact beyond the reported symptoms and events could not be determined, although notes indicated improvement of trochanteric/psoas bursitis post injection and improved back/hip pain.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.In addition improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and subsequent failure/fracture of the components.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include limited range of motion, patient anatomy, postoperative care, surgical technique or abnormal loading of limb.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the documentation provided, the root cause of the ¿broken and dislodged¿ poly liner, reported symptoms, and subsequent revision could not be definitively concluded.However, unable to rule out the reported ¿pop¿ while transferring on/off the hospital toilet ¿later that day¿ of the post-primary right total hip arthroplasty as a contributing factor.The patient also reported sudden knee/leg buckling just days prior to complaints of loud squeaky/creaking/grinding noises after a ¿long walk¿ approximately 3 weeks post-op.The liner alignment in relation to the acetabular shell in the provided intra-op image could not be confirmed as comparison imaging from the immediate post-op phase and/or following the patient reported ¿pop.While transferring on/off toilet in hospital room¿ was not provided.The reported ¿failed liner locking mechanism¿ (and/or the successful locking of the primary liner) could not be confirmed as the explanted liner did not return for evaluation.The patient impact beyond the reported symptoms and events could not be determined, although notes of 05-may-2021 indicated improvement of trochanteric/psoas bursitis post injection and improved back/hip pain.No further medical assessment can be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the acetabular liner, a review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.For the acetabular shell and the polar stem, a review of complaint history revealed similar events for the listed device over the previous 36 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the acetabular liner and the acetabular shell, a review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.In addition improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and subsequent failure/fracture of the components.For the polar stem, a review of the instructions for use documents lists several potential adverse device effects from a hip arthroplasty.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.For the acetabular liner, according with the inspection drawing, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of polyethylene shall be controlled.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy, postoperative care or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 0 DEG XLPE ACET LNR 32MM X 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12104433
• MDR Text Key: 259586772
• Report Number: 1020279-2021-05608
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010598806
• UDI-Public: 03596010598806
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2023
• Device Model Number: 71339550
• Device Catalogue Number: 71339550
• Device Lot Number: 20GM02592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: 08/05/2021; 10/22/2021; 02/02/2022; 09/02/2022; 11/04/2022; Not provided
• Supplement Dates FDA Received: 08/06/2021; 10/22/2021; 02/03/2022; 09/05/2022; 11/11/2022; 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PN: 71335550 / LOT: 20DW12685.; PN: 75100463 / LOT: B2000275.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 73 KG