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

Model Number 75023346

Device Problems Crack (1135); Fracture (1260)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, a polarcup impactor part for handle was found cracked in half.As this was noticed upon field inspection, there was not patient involvement.

Manufacturer Narrative

G3, h2, h3, and h6: it was reported that, a polarcup impactor part for handle was found cracked in half.As this was noticed upon field inspection, there was not patient involvement.The part, intended for used in treatment, was returned for investigation.The part fractured into two pieces.Furthermore, the part shows signs of use.A relationship between device and event can be identified.The production documentation was reviewed.There was no deviation found, which would explain the issue.No further complaint with the same failure mode was reported for the batch in scope.Therefore there's no indication that the device failed to meet specification at time of distribution.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.The received instrument is designed to reposition the polarcup shell.It is therefore subjected to repeated impact forces.Additionally, repeated steam sterilization processes could contribute to an embrittlement.It is however unknown for how many cycles this instrument has been used.A functional test simulating 5 years of use was performed.The observed failure could not be reproduced.Based on the conducted investigations the root cause of the fracture could therefore not be determined conclusively.Nonetheless, in combination with our continuous effort to improve our products, design changes have been implemented to enhance the mechanical behavior of this device.To date no further corrective and preventive actions are planned.Smith and nephew will monitor this device for further similar issues.The returned device will be discarded.H6: update codes.

• Brand Name: POLARCUP IMPACTOR PART FOR HANDLE
• 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
• 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: 12643410
• MDR Text Key: 276858055
• Report Number: 9613369-2021-00388
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07611996112351
• UDI-Public: 07611996112351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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
• Device Operator: Health Professional
• Device Model Number: 75023346
• Device Catalogue Number: 75023346
• Device Lot Number: A55011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1