MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS DIST FEM POLY BUMPER XXSM; LPS AND S-ROM : KNEE FEMORAL

Model Number	1987-17-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/18/2021
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 had a dfr done on (b)(6) 2020.She ruptured her quadriceps tendon in (b)(6) 2020 and now had an infection.The insert, poly button and hinge pin were removed.The joint was washed and scrubbed then a new insert, poly button and hinge pin were implanted.No surgical delay noted.Doi: (b)(6) 2020, dor: (b)(6) 2021, right knee.
Additional Manufacturer Narrative
Product complaint # = >(b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (clinical code) removed clinical symptoms code tendon injury.
Event or Problem Description
Additional information was received stating that there were no implants revised at the time of the extensor mechanism repair.The patella has an implant on it.The implant is not a depuy implant and it was not revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot no lot information available.

• Brand Name: LPS DIST FEM POLY BUMPER XXSM
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11253184
• Report Number: 1818910-2021-02119
• Device Sequence Number: 19524743
• Product Code: JWH
• UDI-Device Identifier: 10603295078975
• UDI-Public: 10603295078975
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K003182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 01/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1987-17-000
• Device Catalogue Number: 198717000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/04/2021; 02/25/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 02/17/2021; 02/25/2021
• 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: ATTUNE REV LPS INSRT XXSM 12MM; COMPETITOR PATELLA; LPS DIST FEM POLY BUMPER XXSM; LPS XX-SM HINGE PIN; ATTUNE REV LPS INSRT XXSM 12MM; LPS DIST FEM POLY BUMPER XXSM; LPS XX-SM HINGE PIN
• Outcome Attributed to Adverse Event: Required Intervention