MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 43/22 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75018942
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because the insert was smaller than it was labeled causing it to fail.Apparently the device was incorrectly manufactured.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed because the insert was smaller that it was labeled, causing it to fail.The surgeon states that the item was manufactured incorrectly.The hospital returned the polarcup xlpe insert 43/22 (75018942, b1913078), used in treatment.A visual assessment can confirm that the insert appears to be smaller than intended, however the device shows extensive wear.The engraved lot and part number are not readable anymore.The reason for the extensive wear cannot be assessed based on the available information, however foreign particles or an inadequate shell size might have contributed to the wear of the implant.With all the medical information provided, a thorough medical assessment was not possible.The production documentation was reviewed in detail, however there are no indications that the device was incorrectly manufactured.All manufacturing documentation was checked for dimensional issues as well as potential mix-up.There are no indications that the device was not manufactured according to specification.Also a mix-up of products cannot be confirmed.One device from the same batch was checked for dimensional issues, however, all measures of the device were within specification.For the batch in scope, no further complaints have been reported in the past.The reported failure is covered in the corresponding risk management file.The ifu lit.No.12.23 ed.05/16 states dislocations and luxations, and abrasion of surfaces as a potential failure mode.The reported failure mode of luxation due to a manufacturing issue cannot be confirmed.There were no deviations found in the manufacturing process.The root cause of this issue stays undetermined after investigation.Should additional information become available, this complaint will be reassessed.To date, no further actions are deemed necessary.Smith and nephew will monitor this device for further similar issues.The device will be retained.

• Brand Name: POLARCUP XLPE INSERT 43/22 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 9874362
• Report Number: 9613369-2020-00070
• Device Sequence Number: 2878254
• Product Code: LPH
• UDI-Device Identifier: 07611996111323
• UDI-Public: 07611996111323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2026
• Device Model Number: 75018942
• Device Catalogue Number: 75018942
• Device Lot Number: B1913078
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR