MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CRS RP INSRT SZ 3 6MM; KNEE TIBIAL INSERT

Model Number	1517-10-306
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Joint Laxity (4526)
Date of Event	09/13/2021
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
The patient's knee was revised to address fell and loosening of the tibial component at the cement to implant interface.Competitor cement was used.Patient fell more than once on operative knee fracturing the patella.When knee was exposed in surgery the constrained tibial insert (size 3 6mm) was 180 degrees backwards.The post had a significant piece sheered off.It appears and in the surgeon's best judgement, that the fall created enough flexion laxity that the poly spun 180 degrees and relocated itself.Doi: (b)(6) 2021, dor: (b)(6) 2021, left knee.
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: a review of the device manufacturing records (dhr) was performed.The review found the product code 151710306 work order (b)(4) was manufactured on 21-feb- 2019.11 parts were manufactured per specification and all raw materials met specification.1 scrap part associated with this lot.1 part scrapped under scrap code a211: scratches.This scrap code has no correlation with the complaint failure mode.No reprocessing associated with this lot.A full review of the dhr and oms history was completed.There was no in process deviations found that could be linked to the complaint failure mode while the parts were being manufactured.Therefore, this complaint was deemed non-verifiable through the device history record review.No further action is required.

• Brand Name: ATTUNE CRS RP INSRT SZ 3 6MM
• Common Device Name: 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12539818
• Report Number: 1818910-2021-21232
• Device Sequence Number: 14478905
• Product Code: NJL
• UDI-Device Identifier: 10603295055686
• UDI-Public: 10603295055686
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 1517-10-306
• Device Catalogue Number: 151710306
• Device Lot Number: 9052360
• 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: 09/13/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• 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: ATTUNE CRS RP INSRT SZ 3 6MM; ATUNE REV RP TIB BASE SZ 3 CEM; COMPETITOR CEMENT MANUFACTURER; UNK ATTUNE KNEE PATELLA; ATTUNE CRS RP INSRT SZ 3 6MM; ATUNE REV RP TIB BASE SZ 3 CEM; COMPETITOR CEMENT MANUFACTURER; UNK ATTUNE KNEE PATELLA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female