MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 71343200

Device Problems Degraded (1153); Device Damaged by Another Device (2915)

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

(b)(6).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

Internal complaint reference (b)(4).

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 did not reveal similar events for the listed device.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.Potential causes could include but are not limited to friction, joint tightness or lifetime 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.

Manufacturer Narrative

Additional information added: d10.

Manufacturer Narrative

H6: health effect - clinical code and health effect - impact code.Section h3, h6: 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 for the part number over the past 24 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.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 friction or joint tightness.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 device was 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 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 order 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 device over the previous 42 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.A review of the instructions for use documents for total hip systems revealed that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.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 specifications at the time of manufacture.Factors that could contribute to the reported event include friction or joint tightness.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: OXINIUM FEM HD 12/14 32MM +0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 12779742
• MDR Text Key: 280527765
• Report Number: 1020279-2021-07923
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474209
• UDI-Public: 03596010474209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71343200
• Device Catalogue Number: 71343200
• Device Lot Number: 20HM02158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• 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): Other; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 73 KG