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 Problem Crack (1135)

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

Event Date 07/07/2021

Event Type  malfunction  

Event Description

It was reported that, after a thr that a polarcup reducer part for impactor plastic was noted to be cracked.Procedure was finished with the same device, no delay reported.Patient status is unknown.

Manufacturer Narrative

H3, h6: it was reported that, after a thr that a polarcup reducer part for impactor plastic was noted to be cracked.The device, intended for use in treatment, was not returned for investigation.The batch number was not communicated and a product evaluation could therefore not be performed.A complaint history review was performed.A relationship between the reported event and the device cannot be confirmed.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Based on the available information, a thorough investigation cannot be conducted and the root cause of the reported issue remains undetermined.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.No further actions have been initiated.If the reported device or additional information become available, this investigation will be reopened.

• 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: 12202941
• MDR Text Key: 262660401
• Report Number: 9613369-2021-00320
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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?: Yes
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1