MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS UNIV RP BRG SM+ 15.0MM; JRN : KNEE TIBIAL INSERT

Catalog Number 177852050

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Product sold prior to procode /510k requirements.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 Description

It was reported that on (b)(6) 2007, the surgery was performed via tka with the implant in question.The surgery was completed successfully without any surgical delay.On nov.2, 2023, spinout was confirmed.Future actions have not yet been determined.Doi: (b)(6) 2007.Unk knee.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device product code - 177852050, lot number - 2272088, and no non-conformances / manufacturing irregularities were identified.Product code 177852050, work order 2272088 lcs rp universal bearings(man) was manufactured on 14-nov-2006.17 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.Expiry date: nov-2011.Ifu reference as per bill of material: 78402905 instruction 902-00-682.Complaint confirmation: non-verifiable.Conclusion: due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.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: a manufacturing record evaluation was performed for the finished device product code - 177852050, lot number - 2272088, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: LCS UNIV RP BRG SM+ 15.0MM
• Type of Device: JRN : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18169751
• MDR Text Key: 328534444
• Report Number: 1818910-2023-23599
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Expiration Date: 11/14/2011
• Device Catalogue Number: 177852050
• Device Lot Number: 2272088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2006
• 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