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

Model Number	75023714
Medical Device Problem Codes	Crack (1135); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the polarcup reducer part for impactor is deformed, has cracks and gouges.No case or patient involved.
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2021-00165
• Device Sequence Number: 19744666
• Product Code: LPH
• UDI-Device Identifier: 07611996114614
• UDI-Public: 07611996114614
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1