MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 14X125MM STR; KNEE IMPLANT

Catalog Number 198725414

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

Patient Problems Adhesion(s) (1695); Fall (1848); Bone Fracture(s) (1870); Pain (1994); Ambulation Difficulties (2544)

Event Date 12/15/2021

Event Type  Injury  

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 Description

Periprosthetic fracture.Doi: unknown.Dor: (b)(6) 2021.Unknown side.

Event Description

Medical records received and were reviewed indicating that the following surgical procedures were noted to have been provided to the patient.However, there is no indication of depuy involvement in any of these procedures.The first instance of depuy implants is the reimplantation surgery (b)(6) 2021.Right total knee arthroplasty performed in (b)(6) of 2014.A right distal femur open reduction internal fixation for a distal femoral fracture in (b)(6) of 2020.A revision of a right total knee arthroplasty due to infection - stage i on (b)(6), 2020 it is also noted that the left side has a total knee implant, but the manufacturer is unknown.Operative notes (b)(6) 2021 indicate the patient received a right total knee reimplantation post infection using lps depuy devices.The patient will continue to receive long-term suppressive antibiotics post reimplantation given her polymicrobial infection.Follow-up office visits indicate the patient is progressing and healing well.Periprosthetic fracture occurred on (b)(6) 2021.Patient fell and sustained a right periprosthetic femur fracture, proximal to a distal femoral replacement while getting out of the bath.The patient is experiencing pain and inability to ambulate.Revision operative notes (b)(6) 2021 indicate the patient received a right total knee revision due to right femur periprosthetic fracture.The procedure entailed: removal of right distal femoral replacement, removal of cement from right femur, synovectomy of the right knee, complex right distal femur replacement revision of knee.Upon entering the knee, adhesions and bone fragments were encountered and removed.The procedure was completed without indication of complication by the surgeon.The surgery was completed without indication of complication by the surgeon.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture or anything indicative of a device nonconformance was found.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.

• Brand Name: LPS CEMENTED STEM 14X125MM STR
• Type of Device: KNEE IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13258645
• MDR Text Key: 283828121
• Report Number: 1818910-2022-00855
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 198725414
• Device Lot Number: J5424N
• 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: 09/25/2020
• 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 CEMENTED STEM 14X125MM STR; LPS DISTAL FEM COMP XSM RT; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XSM 21MM; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE CEM M/L 29MM; S&N RESTRICTOR CEMENT BUCK FLANGE; S&N RESTRICTOR CEMENT BUCK FLANGE; SIG TIB CEM STM 13X60 2/2.5/3; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 107 KG