MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ3 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	196050300
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reported: "i am currently living in syria.In (b)(6) 2021, i had surgery on both my right and left knees.The surgeon recommended it because he connected and has an agreement with the importing company, and we agreed to use johnson & johnson's implants as your company is known for its world-class products and stellar reputation.My condition since the surgery has become worse than it was before.Nowadays, especially the right one, i get tired after walking a short distance and would need to lean on someone.Currently, i am experiencing excruciating pain in both of my knees that have become swollen.Please note that before the surgery, i never experienced these symptoms.The surgeon who performed the procedure and the company is not providing a logical explanation for why i am experiencing pain.".
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.
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.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
Additional information was received: on (b)(6) 2021 patient was noted to have loosening in both knees, but the right knee is more than the left.In the medical records received, the implantation date was listed as the same date of the revision, therefor it is unclear if there was an actual revision.
Additional 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:196050300, lot number:9439397, and no non-conformances / manufacturing irregularities related to the malfunction were identified.Product code 196050300, work order (b)(4) was manufactured on 20-feb-2020.11 parts were manufactured per specification and all raw materials met specification.Scrap: one parts from this lot was scrapped: there is no correlation between this scrap reason and the failure mode of the complaint.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.There is no correlation between this non-conformance and the failure mode of the complaint.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: 196050300, lot number: 9439397, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: SIGMA PS CEM FEM SZ3 R
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18649257
• Report Number: 1818910-2024-02420
• Device Sequence Number: 8200864
• Product Code: JWH
• UDI-Device Identifier: 10603295075134
• UDI-Public: 10603295075134
• Combination Product (Y/N): N
• Initial Reporter Country: SY
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2024

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 Catalogue Number: 196050300
• Device Lot Number: 9439397
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 02/08/2024; 02/13/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/16/2024; 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PFC SIGMA TIB TRAY CEM SZ3; SIGMA PS CEM FEM SZ3 R; SIGMA STAB GVF INS 3 17.5MM; UNKNOWN BONE CEMENT
• Patient Age: 62 YR
• Patient Sex: Female