MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN MED RT 71X66 LPS AND S-ROM : KNEE FEMORAL

Model Number 62-3401R

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

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

Delivery of all the instrumentation and implants, except the noiles femur implants. No possibility to troubleshoot around the clinic because the only depot is in other city (b)(6). Surgery initiated at 2pm and completed at 6pm. The surgeon made the decision to perform the surgery, performed the bone cuts and tests, then put a spacer in place for re-operation on (b)(6) 2022 with the removal of the spacer and the installation of the final implants. The implants were checked only at the time of the intervention by the j&j technical advisor, who warned the surgeon as soon as she had discovered it. The implant kits could not have been shown as missing on the delivery form as it was not reserved. Several elements involved, including the lack of staff of the team ready to sustain quality work.

• Brand Name: SROM NRHFEM W/PIN MED RT 71X66
• Type of Device: LPS AND S-ROM : 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: 14218063
• MDR Text Key: 290145773
• Report Number: 1818910-2022-07627
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K896048
• 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
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 62-3401R
• Device Catalogue Number: 623401R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/27/2022 Patient Sequence Number: 1

Treatment

SROM NRH FEM W/PIN XSMRT 66X58; SROM NRHFEM W/PIN MED RT 71X66; SROM NRHFEM W/PIN SM RT 66X62