MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, POROUS

Catalog Number	OR71332760
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed due to recurrent dislocations.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, the clinical information provided, (b)(6)) the elevated metal ion levels, synovitis and staining may be consistent with a reaction to metal debris.However the source cannot be determined with the available documentation.Also, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The components revised were the bhr resurfacing, the r3 liner and r# shell.In conclusion, for (b)(6) the root cause of the dislocations cannot be concluded, however the mixture of components during the 1st right revision with different manufacturers could have contributed to the issue.It is noted that no x-rays copies or components were returned for this investigation.Patient impact except for the surgeries cannot be predicted and a follow-up status has not been provided at this time.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 part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 60MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8485195
• Report Number: 1020279-2019-01394
• Device Sequence Number: 11208552
• Product Code: MBL
• UDI-Device Identifier: 03596010598028
• UDI-Public: 03596010598028
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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 Catalogue Number: OR71332760
• Device Lot Number: 16MM01995
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR