MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIV FEM SLEEVE CEM 20MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number	1294-53-205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon reported to (b)(6): "sudden increase of pain in the left knee joint after a fall event.".
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: visual examination of the returned cemented sleeve found absence of cement and with burnishing by the proximal end, which is indicative of loosening of the device in situ.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 : 1) quantity manufactured: (b)(4).2) date of manufacture: 03/16/2017.3) any anomalies or deviations identified in dhr: none.4) expiry date: 02/28/2027.5) ifu reference: 020900252 rev l.Device history review: 1) quantity manufactured: (b)(4).2) date of manufacture: 03/16/2017.3) any anomalies or deviations identified in dhr: none.4) expiry date: 02/28/2027.5) ifu reference: 020900252 rev l.

• Brand Name: UNIV FEM SLEEVE CEM 20MM
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13928043
• Report Number: 1818910-2022-05586
• Device Sequence Number: 11190854
• Product Code: JWH
• UDI-Device Identifier: 10603295026259
• UDI-Public: 10603295026259
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-53-205
• Device Catalogue Number: 129453205
• Device Lot Number: H51293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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: LPS DISTAL FEM COMP XSM LT (EX PKT); LPS UNIV TIB HIN INS XSM 12MM; UNK KNEE FEMORAL ADAPTOR LPS; UNK KNEE FEMORAL AUGMENT LPS; UNK KNEE LPS; UNK KNEE STEM LPS
• Patient Sex: Female