MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL/EZE BALL 32 +1 GR; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-21-000

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/05/2022

Event Type  Injury  

Event Description

The patient was revised due to a dislocated prostalac.There was no surgical delay.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Affected side: left hip.

Manufacturer Narrative

Product complaint #
=
> (b)(4).On (b)(6) 2022 : additional information was received from (b)(6)> on (b)(6) 2022 at 6:27 am stating and has been attached to this pc.The head that was removed was (b)(4), lot d21012960.There was no allegation against the cementralizer.The patient either crossed her legs of fell postoperatively which caused the dislocation (head from the poly cup).During surgery, the cup and cement were removed from the acetabulum.The stem was temporarily removed, sequential broaching and calcar planing was performed to seat the stem lower.The original stem was placed back in the femur with the new head.No additional information is available.The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicated that the stem was removed to facilitate acetabular exposure.The proximal femur was then re-broached and the original stem was put back in.The stem was performing as it should.

Manufacturer Narrative

Product complaint #: pc-(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: ARTICUL/EZE BALL 32 +1 GR
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL 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: 15623755
• MDR Text Key: 301911568
• Report Number: 1818910-2022-20645
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033172
• UDI-Public: 10603295033172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883460
• 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,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-21-000
• Device Catalogue Number: 136521000
• Device Lot Number: D21012960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 10/18/2022; 10/26/2022
• Supplement Dates FDA Received: 10/26/2022; 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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: CEMENTRALIZER 10.5.; PROSTALAC ACET CUP 42X32.; UNK HIP FEMORAL STEM CORAIL.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female