MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 32 +9 BL; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136523000

Device Problem Noise, Audible (3273)

Patient Problem Foreign Body Reaction (1868)

Event Date 11/21/2023

Event Type  Injury  

Event Description

Patient operated primary at a private hospital in (b)(6) 2020.Symptoms started in (b)(6) 2023 jarring noise.Patient underwent a revision of the cup/liner on (b)(6) 2023.Head was worn through the liner, and head moved against the cup, a lot of metallosis.Surgeon took out the cup and inserted another cup not from depuy synthes.There was no surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report 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.H10 additional narrative: 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 : patient operated primary at a private hospital (b)(6) 2020.Symptoms started in (b)(6) 2023 jarring noise.Gentofte did a revision of the cup/liner on (b)(6) 2023.Head was worn through the liner, and head moved against the cup, lot of metalosis.Surgeon took out the cup and inserted another cup.Not from depuy synthes.The patient were very upset that she had to go through a revision after only 2½ year.And will make a complaint to the patientorganisation and from there to the health authorities.Was surgery time extended as a direct result of incident? no.It was a planned revision, so not extra time than anticipated.What action was taken/required to manage the problem during the procedure? implanted another cup, but kept the stem.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned found that the articul/eze ball 32 +9 bl has signs of material transfer consistent with the unintended interaction between the femoral head and the cup, it is reasonable to conclude that the audible sound will be present.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed condition of the articul/eze ball 32 +9 bl may have been caused by exposure to irregularities in the weight loading of the device and moments generated.The event is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.The overall complaint was confirmed.As the observed condition of the articul/eze ball 32 +9 bl would contribute to the complained device issue.Based on the investigation findings, with the information provided is not possible to establish a definitive root cause and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation were performed for the finished device 136523000, lot number d19101991, it was manufactured on 30-oct-2019.(b)(4) parts were manufactured per specification and all raw materials met specification, and no non-conformances / manufacturing irregularities were identified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: patient operated primary at a private hospital (b)(6) 2020.Symptoms started in (b)(6) 2023 jarring noise.Gentofte did a revision of the cup/liner on 21 /11-23.Head was worn through the liner, and head moved against the cup, lot of metalosis.Surgeon took out the cup and inserted another cup.Not from depuy synthes.The patient were very upset that she had to go through a revision after only 2½ year.And will make a complaint to the patientorganisation and from there to the health authorities.The product was not returned to depuy synthes, however photos were provided for review.See attachment "x-ray, worn out marathon liner,op 211123".The x-ray review was able to identify the head is not centrally positioned and is making direct contact with the cup, suggesting a disassociation between the liner and the cup.Audible noise can be expected confirming the reported allegation.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed.As the observed condition of the [articul/eze ball 32 +9 bl] would contribute to the complained device issue.  based on the investigation findings, with the information provided is not possible to establish a definitive root cause and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ARTICUL/EZE BALL 32 +9 BL
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18246638
• MDR Text Key: 329486821
• Report Number: 1818910-2023-24440
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033196
• UDI-Public: 10603295033196
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K883460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136523000
• Device Lot Number: D19101991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 01/24/2024; 02/07/2024
• Supplement Dates FDA Received: 01/24/2024; 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PINN MAR +4 10D 32IDX48OD; PINNACLE SECTOR II CUP 48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female