MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	09/10/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a first revision surgery had been performed on plaintiff's left hip on (b)(6) 2014, the plaintiff chronic recurrent dislocations that led to a second revision surgery, which was performed on (b)(6) 2015 to treat the adverse event.The liner, the cup, and the femoral head were replaced.The plaintiff's outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, with the information provided, the clinical root cause of the reported chronic, recurrent dislocations and intraoperative findings of significant amount of fluid and old soft tissue necrosis from the metal-on-metal hip cannot be confirmed, and it cannot be concluded that the reported events and subsequent revision were associated with a mal-performance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 3 HOLE ACET SHELL 60MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12370929
• Report Number: 1020279-2021-06536
• Device Sequence Number: 17172702
• Product Code: MBL
• UDI-Device Identifier: 03596010598288
• UDI-Public: 03596010598288
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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 Expiration Date: 12/12/2018
• Device Model Number: 71335560
• Device Catalogue Number: 71335560
• Device Lot Number: 08MM11547
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN SYNERGY HIP STEM/09JM02821
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR