MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 32MM +9; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-730

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Joint Laxity (4526)

Event Date 04/07/2022

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

It was reported that, the patient had her left hip replaced sometime ago where she received a summit pinnacle construct.She began to have instability issues where she dislocated her hip.The exact time frame after her primary hip and who did her primary hip is unclear.The patient revised her hip where the neutral poly liner and 32mm ceramic hip ball was explanted and a new +4 neutral liner and 32mm + 9 ts hip ball was implanted.This patient had another dislocation and revised her hip once again.The +4 neutral liner and 32mm +9 ts ceramic hip ball were explanted and a 28mmx48mm constrained liner and 28mm +8.5mm ts hip ball were implanted.The summit stem and pinnacle cup were left in situ for both revision surgeries.Doi: unknown, dor: (b)(6) 2022, affected side: 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.

• Brand Name: DLT TS CER HD 12/14 32MM +9
• 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
• 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: 14205888
• MDR Text Key: 290053204
• Report Number: 1818910-2022-07517
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033486
• UDI-Public: 10603295033486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-32-730
• Device Catalogue Number: 136532730
• Device Lot Number: 333935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• 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
• Treatment: ALTRX +4 NEUT 32IDX48OD.; UNK HIP ACETABULAR CUP PINNACLE.; UNK HIP FEMORAL STEM SUMMIT.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female