MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 49/28 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 75018956

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 08/04/2020

Event Type  Injury  

Event Description

It was reported that, after a tha surgery had been performed, the patient experienced a mechanical dislocation of the ceramic ceramic ball head delta 28 m and polarcup xlpe insert 49/28 non-cem.A revision surgery was performed to replace such devices.The patient outcome is unknown.

Manufacturer Narrative

It was reported that, after a tha surgery had been performed, the patient experienced a mechanical dislocation of the ceramic ceramic ball head delta 28 m (75007452) and polarcup xlpe insert 49/28 non-cem (75018956).Both devices used in treatment were received for investigation.A visual inspection was conducted.The polarcup xlpe insert and the ceramic ball head are still connected, indicating that the reported dislocation happened between the insert and shell.The polarcup xlpe insert shows three large dents on the pole of the outer side of the insert.These might origin from impact during dislocation, but also have happened during replacement procedure.Apart from that no obvious damage, such as dents or wear marks, could be observed on the insert.The insert and the ball head were still running smoothly.The size of the polarcup xlpe insert was verified with the "size identification drawing".Size and diameter of the insert are in accordance with the requirements.A medical investigation was performed.Based on the limited information provided, a thorough medical assessment could not be performed.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported dislocation.The ifu (lit.No.12.23 ed 05/16) lists dislocation as a known possible side effect resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the conducted investigation the reported failure mode cannot completely be confirmed.Without further information about the corresponding shell, the root cause for the dislocation of the xlpe insert from the shell cannot be determined.There is no indication that the device failed to match specification at the time of manufacturing and the risk level of this issue is determined as low.Therefore, the need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.The returned device will be retained.

• Brand Name: POLARCUP XLPE INSERT 49/28 NON-CEM
• 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: 10490832
• MDR Text Key: 205586071
• Report Number: 9613369-2020-00163
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07611996111460
• UDI-Public: 07611996111460
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 75018956
• Device Catalogue Number: 75018956
• Device Lot Number: B2004282
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention