MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ4 LM/RL; EARLY INTERVENTION : KNEE FEMORAL

Catalog Number	102407400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).E3: the initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.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 patient was suffering from inflammation, brushing, lack of motion after a partial knee replacement.Doi: (b)(6) 2022.Doe: jun, 2023.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: e1 (hospital), a1, a2 (age), a3a.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, "it was reported that the patient was suffering from inflammation, brushing, lack of motion after a partial knee replacement".The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photographs attached were reviewed, however they do not represent the reported complaint as only the labels with device information can be observed on the 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 overall complaint was not confirmed as the photographs provided are not representative 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 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 product code: 102407400 lot number: jk9657.One nr found.Nr-0169134 related to totes filled above the maximum, no dunnage used, and the configurations shown in mps-100744 were deviated against.Lot jk9657 bounded to nr and dispositioned through (b)(4).

• Brand Name: SIGMA HP UNI FEMORAL SZ4 LM/RL
• Common Device Name: EARLY INTERVENTION : KNEE FEMORAL
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19331675
• Report Number: 1818910-2024-10722
• Device Sequence Number: 15181105
• Product Code: NPJ
• UDI-Device Identifier: 10603295001744
• UDI-Public: 10603295001744
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2024

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: 102407400
• Device Lot Number: JK9657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 06/25/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/31/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2021
• 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: UNKNOWN KNEE IMPLANT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male