MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV DIS POR 31MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number 1294-53-215

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Limb Fracture (4518); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Hcp is reporting a fracture of knee-tep´s femoral sleeve extension right side.Doi: (b)(6) 2021.Dor: (b)(6) 2022.Unknown knee.

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 Description

Additional information received indicated that there was a wrong movement in the swimming pool that caused the bone and implant to break.The tapered connection from stem to sleeve was broken (thread on stem part broken).

Manufacturer Narrative

Product complaint # (b)(4) mfr# 1818910-2022-17922 is being retracted since it was found to be a duplicate of mrf# 1818910-2022-19222.Mfr# 1818910-2022-19222 will be kept for investigation purposes.

• Brand Name: UNIVERSAL FEM SLV DIS POR 31MM
• Type of Device: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15426728
• MDR Text Key: 299938242
• Report Number: 1818910-2022-17922
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295026266
• UDI-Public: 10603295026266
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1294-53-215
• Device Catalogue Number: 129453215
• Device Lot Number: D49GN1A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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 UNIV TIB HIN INS MED 16MM; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 29MM; PFC MOD KNEE SYS TIB FIT FLU STEM 12X75; SIG RPF AOX INS SZ 4 10MM; UNIVERSAL FEM SLV DIS POR 31MM; UNIVERSAL STEM 75X20MM FLUTED; UNIVERSAL STEM 75X24MM FLUTED; UNK KNEE FEMORAL STEM
• Patient Outcome(s): Required Intervention