MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 3 12MM; KNEE TIBIAL INSERT

Model Number	1517-10-312
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	08/12/2020
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
It was reported that the patient's stryker primary knee was revised on (b)(6) 2019.Attune revision components were used to revise the knee.The patient's knee was revised a second time on (b)(6) 2020, due to stiffness.During the second revision procedure, surgeon removed the attune revision insert and then surgically removed (cleaned out) scar tissue throughout the patient's knee.He also performed some soft tissue releases to enable the patient's knee to be fully extended under anesthesia.Because the attune revision insert was scratched and indented during its removal, by the surgical instrumentation that was used to pry it out, a replacement insert of the same size and thickness was implanted.A device experienced report was not submitted for the (b)(6) 2019 revision procedure, since the primary components being revised were stryker components.Doi: (b)(6) 2019.Dor: (b)(6) 2020; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary examination of the returned device confirmed the reported event.The device was found to be scratched and gouged.No evidence was found indicating product error was a contributing factor.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 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H10 additional narrative:.

• Brand Name: ATTUNE CRS RP INSRT SZ 3 12MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10460863
• Report Number: 1818910-2020-18922
• Device Sequence Number: 16832045
• Product Code: NJL
• UDI-Device Identifier: 10603295055716
• UDI-Public: 10603295055716
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 1517-10-312
• Device Catalogue Number: 151710312
• Device Lot Number: 9226229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR