MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C.* FEM AUG TRL SZ-1 DIS-8; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number 866303

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2022

Event Type  Injury  

Event Description

Procedure: revision tka on november, imko hospital: during the procedure, our or technician didn¿t find one of the trial set.The surgeon discovered after the procedure when he was checking the post-op x-ray that the trial set is in the bone of the patient.Now, the patient is under follow-up because he can get an infection.There was a 20 minute surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Udi/gtin marked for exclusion.Product is no longer marketed.(b)(4).Investigation summary: no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: KNEE INSTRUMENT : FEMORAL TRIALS
• 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: 15923195
• MDR Text Key: 304870543
• Report Number: 1818910-2022-24363
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: TS
• 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
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 866303
• Device Lot Number: PG214992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female