MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71337652
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, on (b)(6) 2021, the patient underwent left total hip arthroplasty to improve the structure of the patient's left hip, relieve pain and improve the quality of life.The prosthesis was normal and recovered well after operation.On (b)(6) 2022, the patient felt an abnormal sound of the left hip joint, which was obvious when walking and needed to walk with a crutch.On (b)(6) 2022, a film in the outpatient department of the hospital was taken, which suggested loosening of the r3 20 deg xlpe acet lnr 32 mm x 52 mm.On (b)(6) 2022, the patient underwent surgical incision and exploration, it was found that the liner was loose and the liner buckle was worn, and also that the femoral head was worn; therefore, both components were exchanged.The patient is currently undergoing postoperative rehabilitation treatment.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and they confirm that the liner was no longer in its proper orientation.The clinical/medical investigation concluded that, the provided four x-rays and photo of the explants were reviewed.The x-ray taken prior to the revision and the photo of the explants confirms that the liner was no longer in its proper orientation as reported in the event description.However, the images, do not aid in the clinical investigation of the root cause of the reported loosening of the liner and wear of the femoral head.Therefore, based on insufficient information, a thorough medical assessment could not be performed at this time but the patient impact is limited to the revision procedure.Should any additional relevant clinical information be provided, this complaint would be re-assessed.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.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 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.A review of the instructions for use documents for total hip systems revealed that loosening has been identified as a adverse events in primary and revision surgery.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 and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.The contribution of the device to the reported event could be corroborated since the liner was no longer in its proper orientation.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: R3 20 DEG XLPE ACET LNR 32MM X 52MM
• 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: 13720415
• Report Number: 1020279-2022-01093
• Device Sequence Number: 14608351
• Product Code: JDI
• UDI-Device Identifier: 03596010598493
• UDI-Public: 03596010598493
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71337652
• Device Catalogue Number: 71337652
• Device Lot Number: 20CM01438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 03/15/2022
• Date Device Manufactured: 03/02/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male