MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC SIGMARP CV TB/IN S4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Muscular Rigidity (1968); Osteolysis (2377); No Code Available (3191)
Date of Event	07/03/2019
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 abnormal x-rays indicating lysis and micromotion: abnormal radiographic evaluation event is serious and is considered moderate, and is awaiting revision event is definitely related to device and there is a remote possibility that it is related to procedure.Doi: (b)(6) 2015, doe: (b)(6) 2019, (right knee).
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Additional Manufacturer Narrative
Previous decision was in error.No revision.No serious injury at this time.No confirmed loosening or lysis.
Additional Manufacturer Narrative
Product complaint # (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.Additional narrative: added:implant date, date received by mfr and evaluation codes.Corrected: date of report.Patient code 3191 is used to capture surgical intervention and medical device removal.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).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.H10 additional narrative: added: h6.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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.  h10 additional narrative:  product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 : null.Device history batch: null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMARP CV TB/IN S4 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8835778
• Report Number: 1818910-2019-99450
• Device Sequence Number: 11451823
• Product Code: JWH
• UDI-Device Identifier: 10603295240822
• UDI-Public: 10603295240822
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K961685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/15/2019

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: 96-2042
• Device Catalogue Number: 962042
• Device Lot Number: 7979376
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/12/2019; 08/06/2019; 08/29/2019; 10/15/2019; 03/05/2020
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/07/2019; 08/09/2019; 08/30/2019; 11/07/2019; 03/05/2020
• 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 1 40G.; DEPUY CMW 1 40G.; MBT CEM KEEL TIB TRAY SZ4.; PFC SIG CR NPOR FEM RT SZ 4N.; DEPUY CMW 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ4; PFC SIG CR NPOR FEM RT SZ 4N
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 109