MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71339552
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a hip revision surgery was performed due to sinking of the hip.Liner and ball head exchanged.
Additional Manufacturer Narrative
It was reported that a hip revision surgery was performed due to sinking of the stem.Liner and ball head were exchanged.The affected r3 acetabular liner, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical analysis noted that all documents and images provided as of this date have been reviewed and consider and unless noted do not contribute to the clinical investigation.The impact to the patient beyond the pain and the revision surgery cannot be determined based on the information provided.Probable causes of the reported event could include but are not limited to traumatic injury, user/procedural variance or patient anatomy.Without the return of the actual product involved, our investigation of this report is inconclusive.

• Brand Name: R3 0 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 road; memphis TN 38116
• MDR Report Key: 9396039
• Report Number: 1020279-2019-04225
• Device Sequence Number: 16856971
• Product Code: JDI
• UDI-Device Identifier: 03596010583086
• UDI-Public: 03596010583086
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 08/14/2025
• Device Model Number: 71339552
• Device Catalogue Number: 71339552
• Device Lot Number: 15HM11467
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 122