MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG +4 XLPE ACET LNR 40MM X 58 OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71338696
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/30/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a left hip revision surgery was performed due to instability.
Additional Manufacturer Narrative
The devices, intended for use in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical evaluation was conducted and confirms it cannot be determined to what extent the patient¿s fall, muscle atrophy and tissue loss had on his pain and clinical status.Although the surgeon¿s indication that the significant muscle atrophy and capsule tissue loss may have been contributing factors to the multiple dislocations, the root cause of the reported hip dislocations cannot be confirmed and it cannot be concluded that the dislocations were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 of this event could include traumatic injury or muscle atrophy.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.

• Brand Name: R3 0 DEG +4 XLPE ACET LNR 40MM X 58 OD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9528204
• Report Number: 1020279-2019-04611
• Device Sequence Number: 13552797
• Product Code: MBL
• UDI-Device Identifier: 00885556113103
• UDI-Public: 00885556113103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 04/04/2020
• Device Model Number: 71338696
• Device Catalogue Number: 71338696
• Device Lot Number: 10DM03175
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/11/2020
• 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