MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DLT TS CER HD 12/14 28MM +12; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-28-740

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Joint Dislocation (2374); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.

Event Description

Clinical adverse event received for posterior dislocation.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2014.Date of revision: (b)(6) 2022.Date of event: (b)(6) 2022.(right hip).Treatment: revision; acetabular constraining ring was replaced over the constrained liner/open reduction.

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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

Revision operative notes (b)(6) 2022 indicate the patient received a right total hip revision due to instability and posterior dislocation.Upon entering the joint, significant hematoma was encountered and evacuated.The surgeon also noted that he excised an old femoral bone fragment that was free within the joint not noted to be related to a depuy procedure but likely a previous procedure involving competitor product.The acetabular constraining ring was replaced over the existing constrained liner.The surgery was completed without indication of complication by the surgeon.It is noted in the operative notes that the patient has had multiple dislocations with competitor product prior to this dislocation of depuy product.This instance of revision, (b)(6) 2022, is the first to involve depuy product, based on the information provided.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays and photographs were reviewed and found the evidence provided is not conclusive enough to confirm implant dislocation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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 28MM +12
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15360927
• MDR Text Key: 299288656
• Report Number: 1818910-2022-17152
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033332
• UDI-Public: 10603295033332
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

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: 1365-28-740
• Device Catalogue Number: 136528740
• Device Lot Number: 9768328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 08/25/2022; 10/14/2022
• Supplement Dates FDA Received: 09/13/2022; 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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: APEX HOLE ELIM POSITIVE STOP.; BIOLOX DELTA REVISION HEADTS 12/14 28MM +12.; DEPUY CMW 1 40G.; PINN LNR CON +4 NEUT 28IDX50OD.; PINNACLE 100 ACET CUP 50MM.; STRYKER COMPETITOR CEMENT.; SUMMIT CEMENTED STEM SZ3 HI.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White