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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 10/19/2017

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to recurrent dislocations.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8485195
• MDR Text Key: 141006963
• Report Number: 1020279-2019-01394
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598028
• UDI-Public: 03596010598028
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: OR71332760
• Device Lot Number: 16MM01995
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR