MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 51/28 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 75018957

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026); Insufficient Information (3190)

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

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery performed on an unspecified date, a revision surgery was performed on (b)(6) 2024 in order to replace the polarcup xlpe insert 51/28 non-cem.The reason for the revision and current health status of the patient is unknown.

Manufacturer Narrative

It was reported that, after a total hip replacement surgery performed on an unspecified date, a revision surgery was performed in order to replace the poly liner due to dislocation.The current health status of the patient is unknown.The device used in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (lit.No.12.23, ed.03/21) states detachment of device or device component as a ¿potential adverse device effect¿ resulting from a hip arthroplasty.No clinically sufficient data was provided to perform a medical investigation.The performed investigation does not lead to an accurately determined cause.There is no evidence that the reported devices failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.There is no need for further actions.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.

Event Description

It was reported that, after a thr surgery performed on an unspecified date, a revision surgery was performed on (b)(6) 2024 in order to replace the poly liner due to dislocation.The current health status of the patient is unknown.

• Brand Name: POLARCUP XLPE INSERT 51/28 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
• 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: 18894323
• MDR Text Key: 337548138
• Report Number: 9613369-2024-00021
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07611996111477
• UDI-Public: 07611996111477
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75018957
• Device Lot Number: B2218288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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