MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS SM 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-212
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information received november 1: answers: a.What was the duration of the surgical delay? - 20 minutes.B.Was the device available for return? - yes.C.Was there any adverse consequences that affected the patient because of the reported event? - no, there were no consequences.D.Was there any alleged deficiency to the tibial tray? if yes, please provide details.- the tibial component was functional and also not damaged during the insertion process, so another insert was installed instead of the defective one.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
According to the distributor: revision total knee arthroplasty (s-rom-mbt) was performed.When installing the liner, the doctors found that the inner metal part was not fixed in the liner, so it was impossible to install it.The patient suffered because it became necessary to install a larger liner (14mm), because.The liners were in a single size, there was a delay in the operation.Product photo: attached.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this complaint was not returned.Photo evidence provided was reviewed and insufficient evidence to confirm, the device was damaged upon receipt.It was not possible to determine, the time the device got damaged.However, the device does look separated, but it was not possible to determine if the time of occurrence was prior or after delivery.Additionally, the device presents visible scratches close to the separated portion.The packaging portion visible on the photos does not indicate any damage to it.It only has the cellophane partially removed.The reported damaged upon receipt condition was not confirmed.Additional monitoring, for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device (product code 198727212/lot j95j20) product and lot numbers, and no non-conformances were identified.

• Brand Name: LPS UNIV TIB HIN INS SM 12MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15734902
• Report Number: 1818910-2022-22086
• Device Sequence Number: 15031882
• Product Code: KRO
• UDI-Device Identifier: 10603295079484
• UDI-Public: 10603295079484
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 1987-27-212
• Device Catalogue Number: 198727212
• Device Lot Number: J95J20
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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
• Patient Sex: Unknown