MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S3 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2032
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for hypermobility of the knee and spin out.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2014.Date of revision: unk.Date of event: (b)(6) 2022.(left knee).Treatment: revision; insert was removed.
Additional Manufacturer Narrative
(b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch 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.H10 additional narrative: 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
Operative notes state that total knee arthroplasties on bilateral knees were performed on (b)(6) 2014 utilizing johnson and johnson implants were utilizing including bilateral resurfacing of the patella.The cement manufacturer is not noted, nor is a sticker sheet provided.Clinic notes state that on (b)(6) 2022 the patient has come in for evaluation of her bilateral knee replacements from 8 years prior.Over the past 6 weeks, she has noticed popping in her left knee when she goes from sitting cross-legged to extension.This causes pain and swelling.She has had a brace ¿which has helped a bit.¿ physical examination states she has a lot of varus and valgus laxity in both knees of 4-5mm each.The surgeon states she likely has a spinout of the left knee.The surgeon states she is a good candidate for bilateral knee polyethylene exchanges.This complaint is currently capturing a revision of the insert and will be updated to a planned insert exchange and joint instability.A review of the system will be conducted and if needed, a new complaint will be created regarding the planned poly exchange on the right knee for instability as this pc is capturing the left knee only.Follow-up will also need to be conducted to determine if the revision has now occurred.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not received for examination.Based on the visual analysis of the provided photographic evidence, it cannot be determined a depuy's device failure or malfunction which could contribute to the reported event.No unintended rotation/movement was possible to be observed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PFC SIGMARP CV TB/IN S3 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15568766
• Report Number: 1818910-2022-19908
• Device Sequence Number: 6576146
• Product Code: NJL
• UDI-Device Identifier: 10603295240754
• UDI-Public: 10603295240754
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-2032
• Device Catalogue Number: 962032
• Device Lot Number: 3626763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 10/04/2022; 11/21/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 10/19/2022; 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2013
• 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: DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ2.5; PFC*SIGMA C/R NPOR FEM LT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,35
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White