MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP REDUCER PART FOR IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 75023714

Device Problems Crack (1135); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Event Description

It was reported that the polarcup reducer part for impactor is deformed, has cracks and gouges.No case or patient involved.

Manufacturer Narrative

H3, h6: it was reported that the polarcup reducer part for impactor [article no.: 75023714, batch: d69686] is deformed, has cracks and gouges.No case or patient involved.The device which intent use is in treatment, was returned for investigation.The reported failure of deformation due to compressive stress can be confirmed.The impactor shows deformation, scratches and gouges.A production record review was performed.No deviations were found, which relates to the occurred failure of device.For the batch in scope additional complaints were recorded with similar failure mode.The root cause is attributed to wear and tear.There are no indications that this failure is related to any manufacturing issues.Further corrective and preventive action are not deemed necessary.This version of the device will be monitored for similar issues.The returned device will be retained.

• Brand Name: POLARCUP REDUCER PART FOR IMPACTOR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11708074
• MDR Text Key: 246740252
• Report Number: 9613369-2021-00165
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07611996114614
• UDI-Public: 07611996114614
• Combination Product (y/n): N
• PMA/PMN Number: K110135
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75023714
• Device Catalogue Number: 75023714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1