MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X MM56; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71332756

Device Problem Misassembled (1398)

Patient Problem Injury (2348)

Event Date 11/29/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was carried out for a hip prosthesis exchange due to it broke at the shaft.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this is a duplicate of the case (b)(4) related to a nanos stem, manufactured by third party manufacturer ohst medizintechnik ag.This product is manufactured by ohst medizintechnik ag rathenow and locally distributed by smith & nephew gmbh marl.The investigation activities has been conducted by smith & nephew gmbh marl according to local procedure., therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X MM56
• 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: 8489943
• MDR Text Key: 141158588
• Report Number: 1020279-2019-01409
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598004
• UDI-Public: 03596010598004
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71332756
• Device Lot Number: 15CM03224
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR