MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS PROX FEM STD BODY NEUTRAL; LPS AND S-ROM : KNEE FEMORAL ACCESSORY

Catalog Number	198710105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 patient continues to have recurrent infections and inflammation around patient's prosthesis even after multiple 2 stage revisions.The question has been raised as to whether patient is having a reaction to the metal.Therefore allergy testing is getting done for patient but for that patient needs to know the exact composition of implants so dermatology know what to test for.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.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: since the instrument is not being returned, a physical examination or review of the device history record (dhr) cannot be conducted.H11 additional narrative: added: d10.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: the nature of the query is that this patient continues to have recurrent infections and inflammation around her prosthesis even after multiple 2 stage revisions.The question has been raised as to whether she is having a reaction to the metal.We are therefore getting allergy testing for her but we need to know the exact composition of what we have implanted so dermatology know what to test for.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment (b)(4) fw miro uk_lps and composition mir#30376.The photographs attached were reviewed, however they do not represent the reported complaint.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, and a dimensional inspection and document/specification review were not completed.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of the reported adverse 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 j&j medtech orthopaedics 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: the device lot number is unknown; therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.Device history batch: null.Device history review: null.

• Brand Name: LPS PROX FEM STD BODY NEUTRAL
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21314283
• Report Number: 1818910-2025-02187
• Device Sequence Number: 15491600
• Product Code: JWH
• UDI-Device Identifier: 10603295078623
• UDI-Public: (01)10603295078623
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K003182
• 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: Physician
• Type of Report: Initial,Followup,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
• Operator of Device: Health Professional
• Device Catalogue Number: 198710105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/10/2025; 02/17/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/12/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ARTICUL/EZE BALL 28 +1.5 GR; BI MENTUM PFR CEMENTED CUP 47; BI MENTUM PFR PE LINER 4728; LPS CEMENTED STEM 9X100MM STR; LPS PROX FEM TROC BDY 15DEG LT; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 45MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown