MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 14MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-014

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 01/01/2021

Event Type  Injury  

Event 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.

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.

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.H10 additional narrative:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached photographic evidence, it cannot be determinate a 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
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> 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: LPS UNIV TIB HIN INS XXSM 14MM
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13549619
• MDR Text Key: 285758722
• Report Number: 1818910-2022-02994
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079347
• UDI-Public: 10603295079347
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1987-27-014
• Device Catalogue Number: 198727014
• Device Lot Number: 430318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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; MBT REVISION CEM TIB TRAY S2.5; MBT REVISION CEM TIB TRAY S2.5; P.F.C.* TIB STM EXT 4/5/6 60MM; 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 90 KG