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 Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Ambulation or Postural Difficulties (2544); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	01/01/2021
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
Amputation.The patient received an above the knee amputation due to significant pain, infection, swelling, draining, lymphedema and inability to ambulate.Upon entering the joint, the construct was noted to be grossly loose and infected.The amputation was completed without indication of complication by the surgeon.Doi: (b)(6) 2017; dor: (b)(6) 2021; unknown knee.This complaint is also linked to (b)(4) where the tibial trial was reported.Another pc is linked to this complaint under (b)(4) where the event happened in between apr 2017 ¿ mar 2019.
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.Available xray evidence was reviewed.Based in attached xray images, it cannot be determinate loosening of the implanted product(s) involved in the complaint.No observation of any depuy's device failure or malfunction which could contribute to reported event.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.

• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu IN 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13549622
• Report Number: 1818910-2022-02999
• Device Sequence Number: 5187048
• Product Code: JWH
• UDI-Device Identifier: 10603295216926
• UDI-Public: 10603295216926
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2022

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
• Device Model Number: 86-6404
• Device Catalogue Number: 866404
• Device Lot Number: D15061135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 02/16/2022; 04/01/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 02/25/2022; 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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 XXSM LT.; LPS DISTAL FEM COMP XXSM LT.; LPS FEM TO SLEEVE ADAPTER +10.; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 25MM.; LPS UNIV TIB HIN INS XXSM 14MM.; LPS UNIV TIB HIN INS XXSM 14MM.; MBT REVISION CEM TIB TRAY S2.5.; MBT REVISION CEM TIB TRAY S2.5.; P.F.C.* TIB STM EXT 4/5/6 60MM.; RESTRICTOR CEMENT FEMORAL BUCK FLANGE.; RESTRICTOR CEMENT FEMORAL BUCK FLANGE.; SIG TIB CEM STM 13X60 2/2.5/3; SIG TIB CEM STM 13X60 2/2.5/3.; TRIATHLON AUGMENT CON.; TRIATHLON AUGMENT CONE (5549A140/A916).; UNIVERSAL FEM SLV FUL POR 31MM.; UNIVERSAL FEM SLV FUL POR 31MM.; UNK CABLE/WIRE; UNK CABLE/WIRE.; UNK CABLE/WIRE.; UNK CABLE/WIRE.; UNK KNEE FEMORAL ADAPTOR LPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG