MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPER CEM STEM 13X150MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number 86-6499

Device Problems Fracture (1260); No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2022

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

Surgeon reported to bfarm: "after revision prosthesis of (b)(6) 2021, the patient made a wrong movement in the swimming pool and had pain afterwards.Radiologically, there was a fracture of the connection between the stem and the sleeve with a non-consolidated distal femur fracture on the right." doi: (b)(6) 2021.Dor: (b)(6) 2022.Right side.

Manufacturer Narrative

Product complaint # (b)(4) mfr# 1818910-2022-19221 is being retracted since it was found to be a duplicate of mrf# 1818910-2022-19644.Mfr# 1818910-2022-19644 will be kept for investigation purposes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for analysis.Review of the photographic evidence confirmed the complaint.The femoral stem has fractured.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device 866499 lot number d20031654, and no non-conformances/ manufacturing irregularities were identified 1) quantity manufactured: (b)(4).2) date of manufacture: 16-mar-2020.3) any anomalies or deviations identified in dhr: no non-conformance were identified.4) expiry date: 28-feb-2030.5) ifu reference: ifu-0902-00-252.Device history review: a manufacturing record evaluation was performed for the finished device 866499 lot number d20031654, and no non-conformances/ manufacturing irregularities were identified.

• Brand Name: TAPER CEM STEM 13X150MM
• Type of Device: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15519157
• MDR Text Key: 300992877
• Report Number: 1818910-2022-19221
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295217206
• UDI-Public: 10603295217206
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K882234
• 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,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86-6499
• Device Catalogue Number: 866499
• Device Lot Number: D20031654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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; TAPERED CEMENTED STEMS 13X150MM; UNIVERSAL STEM 75X20MM FLUTED; UNIVERSAL STEM 75X24MM FLUTED; UNK KNEE FEMORAL SLEEVE; UNK KNEE FEMORAL SLEEVE; UNKNOWN KNEE FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Sex: Male