MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 43/22 NON-CEM; PROSTHESISHIPSEMICONSTRAINEDMETALPOLYMERCEMENTED

Model Number 75018942

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a tha had been performed on (b)(6) 2022, the patient experienced a dislocation after becoming intoxicated and falling.It was tried to solve by a close reduction to place head/insert construct back into shell.During reduction the head/insert was difficult to reduce and ultimately the 22mm head dissociated from the xlpe insert.A revision surgery will be performed on an unspecified date.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that, after a tha had been performed on (b)(6) 2022, the patient experienced a dislocation after becoming intoxicated and falling.It was tried to solve by a close reduction to place head/insert construct back into shell.During reduction the head/insert was difficult to reduce and ultimately the 22mm head dissociated from the xlpe insert.A revision surgery will be performed on an unspecified date.Current health status of patient is unknown.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.A review of the complaint history revealed no additional complaint for the batch in question.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Review of past corrective actions was performed.No further escalation is required.The ifu (lit.No.12.23 ed 03/21) lists dislocation as a known possible side effect resulting from a hip arthroplasty.Without the requested clinical information or the device, a thorough medical investigation could not be conducted.Although, the fall cannot be ruled out as a likely contributory factor.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further medical assessment is warranted at this time.Based on the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.The root cause for the reported dislocation is attributed to a known inherent risk of the device.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: POLARCUP XLPE INSERT 43/22 NON-CEM
• Type of Device: PROSTHESISHIPSEMICONSTRAINEDMETALPOLYMERCEMENTED
• 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: 14142968
• MDR Text Key: 289520618
• Report Number: 9613369-2022-00219
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07611996111323
• UDI-Public: 07611996111323
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

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: 75018942
• Device Catalogue Number: 75018942
• Device Lot Number: B1900623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention