MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 50MM; PROSTHESIS,HIP,SEMI-CONSTRAINED,MTL/CRMC/CRMIC/METAL, CEMENTED OR UNCEMENTED

Catalog Number	71335550
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had an mri performed and received an epidural steroid shot due to pain and numbness in knee.Doctor relates it to the hip prosthesis.
Additional Manufacturer Narrative
The affected r3 3hole acetabular shell, r3 0 deg acetabular liner and reflection spherical head screws were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Therefore, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batches which did not reveal any deviation from the standard manufacturing processes.Our clinical evaluation noted that the patient¿s complaint of vision problems relating to either titanium toxicity or lt tha metallosis cannot be determined and is not supported by the multiple clinical visits nor the provided lab values which don¿t include metal ion levels.There is no supporting clinical documentation to draw a causal relationship with the reported symptoms and the device.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE ACET SHELL 50MM
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,MTL/CRMC/CRMIC/METAL, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8167751
• Report Number: 1020279-2018-02797
• Device Sequence Number: 195276
• Product Code: MRA
• UDI-Device Identifier: 03596010598233
• UDI-Public: 03596010598233
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 08/12/2021
• Device Catalogue Number: 71335550
• Device Lot Number: 11HM09036
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/15/2018
• Supplement Report FDA Received Date: 06/18/2019
• 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: Other