MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +5.0; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-720

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation record received.Litigation alleges hematoma left hip with severe metallosis.Patient suffered economic damages, pain, injuries and emotional distress.(b)(6) 2019 mri reported progressive left hip joint effusion and synovial hypertrophy with alval and pseudotumor along with nondisplaced trochanteric fracture.Doi: (b)(6) 2019; dor: (b)(6) 2019; left hip 2nd revision.

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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DLT TS CER HD 12/14 36MM +5.0
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12293828
• MDR Text Key: 265584398
• Report Number: 1818910-2021-17375
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033660
• UDI-Public: 10603295033660
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1365-36-720
• Device Catalogue Number: 136536720
• Device Lot Number: 9057980
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No