MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT NAV 22/63; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 75023366

Device Problem Crack (1135)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported during a field inspection that a polarcup trial insert nav 22/63 was found to be cracked.No case involved.

Manufacturer Narrative

It was reported that during a field inspection a polarcup trial insert nav 22/63 was found to be cracked.No case involved.The device use in treatment was returned for investigation.The reported failure mode could be confirmed upon visual inspection.The device is observed to be fractured.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record does not indicate that the device failed to match specification at the time of manufacturing.The device was manufactured in 2011.Based on the performed investigations, the reported damage could be confirmed.The relationship between the reported event and the device was confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Normal wear and tear through repeated impaction are known to contribute to the reported event.Additionally, repeated steam sterilization processes could contribute to an embrittlement.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.It is unknown for how many cycles this instrument has been used.Therefore, the root cause stays undetermined after investigation.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor the device for similar issues.The returned device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT NAV 22/63
• 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: 12558656
• MDR Text Key: 274264961
• Report Number: 9613369-2021-00378
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07611996112559
• UDI-Public: 07611996112559
• 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
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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: 75023366
• Device Catalogue Number: 75023366
• Device Lot Number: A75259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1