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

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994); Joint Dislocation (2374)

Event Date 01/03/2020

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 medical records received.After review of medical records patient was revised to addressed recurrent anterior superior dislocation.Prior to revision patient alleges pain, discomfort, dislocation with closed reduction and fall.Clinic reports reported of squeaking.Doi: (b)(6) 2019, dor: (b)(6) 2020, right hip 2nd revision.Please see (b)(4) right hip 1st revision.(b)(4) left hip.

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.H10 additional narrative:.

• 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: 10991799
• MDR Text Key: 220929093
• Report Number: 1818910-2020-26798
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033660
• UDI-Public: 10603295033660
• Combination Product (y/n): N
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-36-720
• Device Catalogue Number: 136536720
• Device Lot Number: 9246269
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 36IDX54OD; DLT TS CER HD 12/14 36MM +5.0; ALTRX +4 10D 36IDX54OD; DLT TS CER HD 12/14 36MM +5.0
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR