MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HIP BALL BIOLOX 32 +5 12/14; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 9111132

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hematoma (1884); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

(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

On (b)(6) 2019, the patient underwent a left hip revision due to mechanical complication of internal joint implant.The surgeon noted a hematoma, discoloration from metal abrasion, and the removal of scar tissue.The liner was worn and disassociated from the cup with minor contact of the head against the metal ring.The head and liner were exchanged.The cup and stem were retained.There were no indicated intra-operative complications.Doi: (b)(6) 2015, dor: (b)(6) 2019, left hip.

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.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device did not identify any product defects or anomalies.This device was manufactured on 20-oct-2014.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.

• Brand Name: HIP BALL BIOLOX 32 +5 12/14
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11649722
• MDR Text Key: 244915720
• Report Number: 1818910-2021-07668
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9111132
• Device Lot Number: 8002718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP.; CORAIL CEM STEM STD S11.; PINN MAR +4 10D 32IDX48OD.; PINNACLE 100 ACET CUP 48MM.; APEX HOLE ELIM POSITIVE STOP; CORAIL CEM STEM STD S11; PINN MAR +4 10D 32IDX48OD; PINNACLE 100 ACET CUP 48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR