MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 26 20 DEG 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after primary thr, patient suffered a dislocation and a revision surgery was performed to explant a reflection xlpe 26id 20 degree 54-56 od size f.The outcome of the patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device is heavily worn from implantation.The clinical medical investigation concluded that this case reports that a revision thr surgery was performed due to dislocation.There are photos of the explanted head and liner, which both show wear.However, per email correspondence, the requested surgical reports and x-rays are not available.Therefore, the patient impact beyond the revision and the clinical root cause of the dislocation cannot be determined.Due to the limited information provided, no further clinical assessment can be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include surgical technique, traumatic injury or wear.Based on this investigation, the need for corrective action is indicated.Should 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.Additional information: d3, d8/d9.
Additional Manufacturer Narrative
H3, h6.The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device is heavily worn from implantation.The lab analysis showed scratching of the femoral head; deformation of the femoral head, taper sleeve, and the acetabular liner; and discoloration of the acetabular liner.The scratching of the femoral head was likely due to explantation.The deformation of the femoral head, taper sleeve, and rim of the acetabular liner was likely due to explantation as well.The discoloration of the acetabular liner was likely to the absorption of biological fluids.A wear inspection was conducted by placing the femoral head into the acetabular liner and visually inspecting the conformity between the mating components.Based on this visual assessment, minimal gaps were observed indicating minimal wear of the acetabular liner.No material or manufacturing deviations were observed during the investigation of this device.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that case reports that a revision thr surgery was performed due to dislocation.There are photos of the explanted head and liner, which both show wear.However, per email correspondence, the requested surgical reports and x-rays are not available.Therefore, the patient impact beyond the revision and the clinical root cause of the dislocation cannot be determined.Due to the limited information provided, no further clinical assessment can be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could not be corroborated.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.Internal reference number: (b)(4).

• Brand Name: REF XLPE 26 20 DEG 54-56 F
• Common Device Name: 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: 11393200
• Report Number: 1020279-2021-01726
• Device Sequence Number: 19124302
• Product Code: JDI
• UDI-Device Identifier: 03596010455581
• UDI-Public: 03596010455581
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2011
• Device Model Number: 71333315
• Device Catalogue Number: 71333315
• Device Lot Number: 01DM08088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 04/05/2022
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 08/15/2021; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown