MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG +4 XLPE ACET LNR 40MM X 56OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71338704

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Event Description

It was reported that patient had primary thr in (b)(6) 2018 and it had dislocated several times since.A revision surgery was performed to exchange liner and femoral head.

Manufacturer Narrative

The associated complaint devices were not returned.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 batches.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 20 DEG +4 XLPE ACET LNR 40MM X 56OD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8222152
• MDR Text Key: 132226854
• Report Number: 1020279-2019-00074
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556113042
• UDI-Public: 00885556113042
• Combination Product (y/n): N
• PMA/PMN Number: K093363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Catalogue Number: 71338704
• Device Lot Number: 10AM10418
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR