MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG +4 XLPE ACET LNR 44 X 62; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71330012
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/05/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported left hip revision surgery, performed due to pain and instability.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical evaluation was conducted and confirms the patients wrestling and subsequent fall cannot be ruled out as contributing factors to his pain and clinical status.The extreme anteversion of the acetabulum cannot be ruled out as a contributing factor to the pain and clinical status of the patient, and it cannot be concluded that the reported events are 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.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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 for this event could include device alignment or a traumatic injury.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.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 0 DEG +4 XLPE ACET LNR 44 X 62
• 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: 9171670
• Report Number: 1020279-2019-03601
• Device Sequence Number: 11377467
• Product Code: MBL
• UDI-Device Identifier: 03596010651907
• UDI-Public: 03596010651907
• Combination Product (Y/N): N
• PMA/510(K) Number: K093363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 02/04/2021
• Device Model Number: 71330012
• Device Catalogue Number: 71330012
• Device Lot Number: 11BM04094B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 04/21/2020
• 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: Hospitalization; Required Intervention