MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 115X18MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7432
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032)
Date of Event	06/09/2021
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
It was reported that the patient has had multiple operations.Implant dates relating to this surgery are as follows: stem, sleeve and cable on (b)(6) 2018.Distal femur and insert on (b)(6) 2020.This complaint captures the patella tendon rupture repair (b)(6) 2020.Patient had a patella tendon rupture after her surgery on (b)(6) 2020 which was repaired on the (b)(6) 2020 surgery.Doi (b)(6) 2021 adapter.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 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 : 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: UNIVERSAL STEM 115X18MM FLUTED
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12041677
• Report Number: 1818910-2021-13268
• Device Sequence Number: 14499993
• Product Code: JWH
• UDI-Device Identifier: 10603295217923
• UDI-Public: 10603295217923
• 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: 2018
• 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,Followup
• Report Date (Section B): 06/09/2021

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: 86-7432
• Device Catalogue Number: 867432
• Device Lot Number: C90328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 06/23/2021; 06/23/2021; 08/06/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/05/2021; 07/08/2021; 08/06/2021
• 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; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; CONTROL CABLE W/CABLE SLEEVE; DEPUY BONE CEMENT; LPS DISTAL FEM COMP XXSM RT; LPS FEM TO SLEEVE ADAPTER +0; LPS XX-SM HINGE PIN; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 115X18MM FLUTED; UNK ATTUNE KNEE TIBIAL TRAY; ATTUNE REV LPS INSRT XXSM 12MM; CONTROL CABLE W/CABLE SLEEVE; DEPUY BONE CEMENT; LPS DISTAL FEM COMP XXSM RT; LPS FEM TO SLEEVE ADAPTER +0; LPS XX-SM HINGE PIN; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 115X18MM FLUTED; UNK ATTUNE KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR