MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 4N; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	94-0019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Clinical adverse event received for arthrofibrosis: adhesions; event is serious and is considered moderate; event is possibly related to device and is probably related to procedure.Date of implantation: (b)(6) 2020; date of event (onset): (b)(6) 2020; (left knee).
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.
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: b5, h6 (patient).H6 patient code: no code available (3191) was used to capture joint instability.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
On (b)(6) 2020, the patient underwent a primary left knee revision with no indicated intra-operative complications.On(b)(6) 2020, the patient presented for a left knee evaluation due to adhesions/arthrofibrosis, slight instability, decreased range of motion, and non-progressing physical therapy.On (b)(6) 2020, the physician noted the patient was continuing physical therapy with improving range of motion.On (b)(6) 2020, the patient underwent a left knee closed manipulation under anesthesia due to adhesions/arthrofibrosis and stiffness.The procedure was completed without apparent intra-operative complications.No products were revised.

• Brand Name: SIG C/R POROCOAT FEM LT SZ 4N
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10352245
• Report Number: 1818910-2020-17312
• Device Sequence Number: 16808174
• Product Code: JWH
• UDI-Device Identifier: 10603295223450
• UDI-Public: 10603295223450
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2020

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 Model Number: 94-0019
• Device Catalogue Number: 940019
• Device Lot Number: J4511W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020; 08/31/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/07/2020; 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 2 20G; MBT POR TIBIAL TRAY SZ3; PFC SIGMA/OV/DOME PAT 3PEG,35; SIG C/R POROCOAT FEM LT SZ 4N; SIG RP AOX CRV INS SZ4 12.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 81