MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID INTL DLT CER LNR 62MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71331762

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

Patient Problem Unspecified Infection (1930)

Event Date 01/16/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed and an infection was confirmed.Liner was removed.An antibiotic spacer was used.

Manufacturer Narrative

It was reported that a revision surgery was performed due to pain, stem subsidence and movement.The affected anthology offset stem, biolox delta head and r3 delta ceramic liner, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the adverse event could not be corroborated.A medical analysis noted that three undated x-rays were provided for review but did not indicate a reason for the stem subsidence.No other additional relevant information has been provided.Without the return of the actual product involved, our investigation of this report is inconclusive.Some potential causes of the reported event could include but are not limited to traumatic injury, patient anatomy or patient non-compliance.

• Brand Name: R3 36MM ID INTL DLT CER LNR 62MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9636127
• MDR Text Key: 176552639
• Report Number: 1020279-2020-00400
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331762
• Device Lot Number: 15KT59865
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention