MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. BIOLOX DELTA; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 1365-32-310

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

Md was using trail head to fit total hip joint.Trial head popped off and migrated into patient pelvis.Md unable to remove from patient.Vendor was with surgeon in the or.Depuy vendor provided trail head.Manufacturer response for depuy trial head, head femoral +1mm 12/14 taper 32mm hip blx d articul/eze (per site reporter).= vendor reviewed with their leadership and stated unable to determine if there was an issue with the trail head, or if this was user error by the md.No additional info available.

• Brand Name: BIOLOX DELTA
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 16385359
• MDR Text Key: 309654921
• Report Number: 16385359
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-32-310
• Device Catalogue Number: 136532310
• Device Lot Number: 3934425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2023
• Date Report to Manufacturer: 02/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA