MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN MED RT 71X66; LPS AND S-ROM : KNEE FEMORAL

Catalog Number	623401R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported revision was completed due to infection.Poly liner and hinge pin were revised and washout was completed.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, ¿attune lps srom hinge knee [date]@ [hospital] with [surgeon], reason for surgery was following a primary tka (medacta) that was went through a 1st stage revision.Infection persisted and required washout of implants [date]@ [hospital] [surgeon] decided not to replace the implants.Repeat washout [date] by [surgeon] resulted in replacement of polly liner and hinge pin.¿ the product was not returned to depuy synthes, however photos were provided for review.Review of the photographic evidence only shows the patient labels of the reported srom nrhfem w/pin med rt 71x66.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.As the device was not returned, an as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation and sterile product documentation review were performed for the finished device [623401r / m1208h] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of the reported event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a manufacturing record evaluation was performed for the finished device [623401r / m1208h] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review a manufacturing record evaluation was performed for the finished device [623401r / m1208h] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: SROM NRHFEM W/PIN MED RT 71X66
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19839409
• Report Number: 1818910-2024-16049
• Device Sequence Number: 7816099
• Product Code: KRO
• UDI-Device Identifier: 10603295179474
• UDI-Public: (01)10603295179474(11)221001(17)270930(10)M1208H
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K896048
• 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): 07/26/2024

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: 623401R
• Device Lot Number: M1208H
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2022
• 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 MED 26MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown