MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ARTICUL/EZE BALL 32 +5 BR; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136522000

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

Patient Problems Foreign Body Reaction (1868); Physical Asymmetry (4573)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that "i have had it reported to be today that a corail pinnacle had to be revised due to the pinnacle liner becoming unseated in the pinnacle cup." liner dislocated.Short limb.Metallosis from head articulating with superior aspect of shell.Cup directly over tal.Both components well fixed.No.Neck impingement.No damage to trunnion once head removed.Short external rotators intact.Decision made that due to patients age, frailty and significant comorbidities and lack of bone around oversized cup, not for acetabular revision.No evidence of infection.

Manufacturer Narrative

Product complaint (b)(4).D4 the device catalog number is unknown; therefore, udi is unavailable.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: added: b5, h6 health effect - impact code if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d10 concomitant.

Event Description

Additional information received states that this was a revision case due to the issue with the liner, so the case took 1 ½ hours.

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: it was reported that "i have had it reported to be today that a corail pinnacle had to be revised due to the pinnacle liner becoming unseated in the pinnacle cup." liner dislocated.Short limb.Metallosis from head articulating with superior aspect of shell.Cup directly over tal.Both components well fixed.No.Neck impingement.No damage to trunnion once head removed.Short external rotators intact.Decision made that due to patients age, frailty and significant comorbidities and lack of bone around oversized cup, not for acetabular revision.No evidence of infection.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the outer surface of the articul/eze ball 32 +5 br presents signs of what appears to be metal transfer, most likely caused by the head being in contact with the acetabular cup after the disassociation event occurred.The observed condition does not represent a device nonconformance.A manufacturing record evaluation was performed for the finished device [136522000/ d14021797] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the articul/eze ball 32 +5 br would not contribute to the complained disassociation event.Based on the investigation findings, 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 reported 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 136522000, lot number d14021797, it was manufactured on 25-feb-2014.37pcs parts were manufactured per specification and all raw materials met specification, and no non-conformances / manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device [136522000/ d14021797] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: ARTICUL/EZE BALL 32 +5 BR
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18240108
• MDR Text Key: 329429420
• Report Number: 1818910-2023-24401
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033189
• UDI-Public: 10603295033189
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 11/30/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 136522000
• Device Lot Number: D14021797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2014
• 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: PINN MAR NEUT 32IDX56OD; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE
• Patient Outcome(s): Required Intervention