MAUDE Adverse Event Report: DEPUY IRELAND 9616671 PFC SIG RPF INS SZ 5 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Ambulation or Postural Difficulties (2544)
Date of Event	05/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
(b)(6).Clinical adverse event received for loss of movement in knee post total knee replacement.Needed manipulation under anaesthetic: adhesions.Event is not serious and is considered moderate.Event is definitely related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2015.Date of event (onset): (b)(6) 2015.(left knee).Treatment: manipulation under anesthesia, celestone & naropin injection, physiotherapy.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : dhr review was performed as part of (b)(4).Dhr was reviewed for product code 951050, work order /lot no.(b)(4) and no deviations were noted.

• Brand Name: PFC SIG RPF INS SZ 5 10MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13266320
• Report Number: 1818910-2022-00978
• Device Sequence Number: 1508354
• Product Code: NJL
• UDI-Device Identifier: 10603295230458
• UDI-Public: 10603295230458
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: 95-1050
• Device Catalogue Number: 951050
• Device Lot Number: 581291
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 2G 40G; DEPUY DUOFIX MBT TRAY SZ 4.5; PFC SIG RPF INS SZ 5 10MM; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG PS150 FEM COMP SZ 5 L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 100 KG