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  malfunction  

Event Description

It was reported that patient had primary "thr" in (b)(6) 2018, and patient had a dislocation.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical medical team noted no clinically relevant supporting documentation was provided; therefore a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.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.No further actions are being taken at this time.We consider this investigation closed.

• 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: 8223111
• MDR Text Key: 132272236
• Report Number: 1020279-2019-00085
• 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: 04/12/2019

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
• 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