MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71335554
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to consistent pain.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, the x-rays provided do not contribute to the reported complaint.Although it was reported that the patient had pain, elevated metal levels as well as fluid, synovitis, and corrosion which are consistent with an adverse reaction to metal debris without the analysis of the explanted components, the source cannot be confirmed but the corrosion at the modular head cannot be ruled out.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The future impact to the patient beyond the revision cannot be determined.No further clinical assessment is warranted.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: R3 3 HOLE ACET SHELL 54MM
• 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: 8396905
• Report Number: 1020279-2019-00950
• Device Sequence Number: 16191093
• Product Code: MBL
• UDI-Device Identifier: 03596010598257
• UDI-Public: 03596010598257
• 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: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 12/05/2019
• Device Catalogue Number: 71335554
• Device Lot Number: 09MM04045
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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
• Patient Age: 73 YR