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

Catalog Number	196040300
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "it was reported that "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.Sadly, 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.What i would like to know is whether the products used in my procedure are defective or original, enclosed at the end of this letter is the code of the johnson & johnson products used in the surgery (tibial and femoral) i am optimistic that you will help me to feel better and get back my health.And i order from your company and doctors team to find a solution for my condition.I can attach panoramique pictures or live videos for my knees if u want"" the product was not returned to depuy synthes, however photos were provided for review.See attachment adobe pdf (b)(4) x-ray films ad 29 jan 2024.The photo/x-ray investigation revealed that there were no product problems observed with sigma ps cem fem sz3 l.Based on the provided evidence, the allegation of loosening can not be confirmed.The overall complaint was unconfirmed as the observed condition of the pfc sigma tib tray cem sz3 would not contribute to the complained device issue.Based on the investigation findings and 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 20-nov-2018.3) any anomalies or deviations identified in dhr: 1, no correlation between this non-conformance and the failure mode of the complaint.4) expiry date: 31-oct-2028.5) ifu reference: 090200252.A manufacturing record evaluation was performed for the finished device (lot number: 8970106), and no non-conformances / manufacturing irregularities related to this event were identified.

• Brand Name: SIGMA PS CEM FEM SZ3 L
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18639110
• Report Number: 1818910-2024-02318
• Device Sequence Number: 8092400
• Product Code: JWH
• UDI-Device Identifier: 10603295075042
• UDI-Public: 10603295075042
• 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): 02/05/2024

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: 196040300
• Device Lot Number: 8970106
• 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: 02/13/2024; 04/25/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 02/16/2024; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• 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 Age: 62 YR
• Patient Sex: Female