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 Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a thr surgery, the polarcup reducer part for impactor broke.The procedure was resumed, without any delay, by changing the surgical technique.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H11: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the impactor tip broke during use.However, upon visual analysis of the returned device, it was determined that the issue does not meet the criteria to be reportable, since the tip is severely deformed instead.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.

• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15709462
• Report Number: 9613369-2022-00586
• Device Sequence Number: 14738601
• Product Code: LPH
• UDI-Device Identifier: 07611996114614
• UDI-Public: 07611996114614
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown