MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C.* TIB STM EXT 4/5/6 60MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-6404
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2020
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
Surgeon reported to bfarm: "the knee endoprosthesis was implanted in 2002.Since 2013, loosening of the prosthesis and fracture of the tibial stem is known.Due to multiple internal diseases, the patient was not able to undergo surgery up to now.Now, knee-tep removal was performed because of knee-tep loosening and stem-fracture.".
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not 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.
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.
Event or Problem Description
Additional information received states that both bone-cement interface and metal-cement interface showed fringing.The affected side of the patient was the right knee and surgery's time wasn¿t extended.
Event or Problem Description
Both tibial and femoral components were loosened.
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.

• 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: 11584827
• Report Number: 1818910-2021-06366
• Device Sequence Number: 17354924
• Product Code: JWH
• UDI-Device Identifier: 10603295216926
• UDI-Public: 10603295216926
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 86-6404
• Device Catalogue Number: 866404
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 04/30/2021; 06/02/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/08/2021; 05/28/2021; 06/02/2021
• 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: P.F.C.* TIB STM EXT 4/5/6 60MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC* MOD PLUS TIBIAL TRAY SZ 4; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA TC3 INS 15MM, SZ 4; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention