MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ4; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number 96-0089

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/09/2022

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

The patient was revised due to loosening of the unknown component at the unknown interface.Cement manufacturer was unknown.It was also reported that the patient broke the adaptor and adaptor bolt for the second time.Bone has resorbed around the implant creating almost a distal femoral replacement situation.Adaptor bolt, adaptor, femoral component and insert were removed leaving the tibial component and femoral sleeve and stem well fixed in the patient.A hinged component was then prepped for and impacted into the sleeve that was well fixed in the bone and a lps insert was inserted.Doi: (b)(6) 2017.Dor: (b)(6) 2022.Right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

• Type of Device: SIGMA REVISION IMPLANT : KNEE FEMORAL
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16033324
• MDR Text Key: 305980832
• Report Number: 1818910-2022-25996
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-0089
• Device Catalogue Number: 960089
• Device Lot Number: 2551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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: PFC SIGMA FEM POST AUG SZ4 4MM.; PFC SIGMA FEM POST AUG SZ4 8MM.; PFC*SIGMA DIS AUG 8MM,SZ4,RGHT.; PFC*SIGMA TC3 FEM RT SZ4.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SIGMA FEM ADAPTER 5 DEGREE.; TC3 RP TIBIAL INSERT S4,22.5.; UNKNOWN BONE CEMENT.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 122 KG