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

Model Number	75023714
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: (b)(4).
Event or Problem Description
It was reported that the impactor tip broke during impaction.No parts fell into patient.The procedure was completed using a sn backup device.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
After the device was received, it could be confirmed that the device 75023714 (polarcup reducer part for impactor), lot a52522, did not break inside the patient but got deformed instead.Since no pieces could fell into the patient¿s incision and there are no previous events that led to serious injury nor is foreseeable this event could lead to a serious injury if it were to recur, this event does not meet the threshold for reporting and is a non-reportable event.

• Brand Name: POLARCUP REDUCER PART FOR IMPACTOR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11396838
• Report Number: 9613369-2021-00084
• Device Sequence Number: 14274346
• Product Code: JDI
• UDI-Device Identifier: 07611996114614
• UDI-Public: 07611996114614
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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
• Device Lot Number: A52522
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1