MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 6 12MM; KNEE TIBIAL INSERT

Model Number	1517-10-612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscular Rigidity (1968)
Date of Event	11/13/2020
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 surgeon said that the patient came to see him because his knee felt a little tight.He decided to take him to surgery and do a soft tissue releases and possible poly swap.He decided after doing the releases that the knee still felt a little stiff and decided to go to a smaller poly.The implant was probably not oversized on the primary surgery.The patient¿s knee might have seemed tighter due to soft tissue or possible constraints on rehab.Surgeon replaced the poly with the appropriate size and washed out the knee.Doi: (b)(6) 2019, dor: (b)(6) 2020, right 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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CRS RP INSRT SZ 6 12MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10935211
• Report Number: 1818910-2020-25941
• Device Sequence Number: 14535569
• Product Code: NJL
• UDI-Device Identifier: 10603295056041
• UDI-Public: 10603295056041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 1517-10-612
• Device Catalogue Number: 151710612
• Device Lot Number: 9023054
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR