MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 LPS FEM TO SLEEVE ADAPTER +5; LPS AND S-ROM : KNEE FEMORAL ACCESSORY

Catalog Number	198706005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the following implants subsided.Right lps distal femur, universal femoral sleeve, lps adapter and universal stem sub-sited leaving patients leg short on that right side.Also the attune revision tibia, attune revision tibial sleeve and stem were loose.Surgeon explanted all implants except the patella.Surgeon revised and replaced the implants.There was loosening of all implants at the bone to cement interface.Doi: (b)(6) 2023, dor: (b)(6) 2024, affected side: right knee.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS FEM TO SLEEVE ADAPTER +5
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19033295
• Report Number: 1818910-2024-07415
• Device Sequence Number: 8167308
• Product Code: JWH
• UDI-Device Identifier: 10603295078494
• UDI-Public: 10603295078494
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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 Catalogue Number: 198706005
• Device Lot Number: J87M98
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE REV LPS INSRT XXSM 14MM; ATUN PRESSFIT STR STEM12X110MM; ATUN TIB AUG LM/RL SZ 3/4 10MM; ATUN TIB AUG RM/LL SZ 3/4 10MM; ATUN TIB SLV M/L 29MM FULL POR; ATUNE REV RP TIB BASE SZ 3 CEM; LPS DISTAL FEM COMP XXSM RT; UNIVERSAL FEM SLV FUL POR 40MM; UNIVERSAL STEM 75X20MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male