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	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	08/06/2020
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
The patient was revised to address pain and loosening of the unknown component at the cement to implant and bone to cement interface.The sleeve /stem interface broke.Unknown cement was used.No surgical delay.No additional information is available.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.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.

• 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
• MDR Report Key: 10426330
• Report Number: 1818910-2020-18368
• Device Sequence Number: 11543805
• Product Code: JWH
• UDI-Device Identifier: 10603295026259
• UDI-Public: 10603295026259
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K063633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1294-53-205
• Device Catalogue Number: 129453205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 09/27/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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: LPS DISTAL FEM COMP XSM RT (EX PKT); LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XSM 23MM; TAPER CEM STEM 13X90; LPS DISTAL FEM COMP XSM RT (EX PKT); LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XSM 23MM; TAPER CEM STEM 13X90
• Outcome Attributed to Adverse Event: Required Intervention