MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 32 +13 BLK; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number	136524000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Corail pinnacle metalose.First implantation 2001, dor: 02 nov 2023, affected side: right hip.
Additional 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.
Additional 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.
Event or Problem Description
Additional information received: a, was there a surgical delay? if yes, what is the duration of the delay? no b.It was stated that the corail pinnacle metalose in the event description.Yes, ultamet.C.Please clarify if there was implant loosening elevated metal ions or foreign body reaction, etc.Please kindly provide details.Yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, first implantation 2001 right hip, corail pinnacle metalose the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a photo review from attachment img_0238.Jpeg.The x-ray investigation revealed that the articul/eze ball 32 +13 blk presented no evidence of implant fracture or anything indicative of the device nonconformance.The overall complaint was not confirmed as the observed condition of the articul/eze ball 32 +13 blk would not contribute to device nonconformance.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 records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: ARTICUL/EZE BALL 32 +13 BLK
• Common Device Name: 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): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18181808
• Report Number: 1818910-2023-23786
• Device Sequence Number: 7653522
• Product Code: JDI
• UDI-Device Identifier: 10603295033202
• UDI-Public: 10603295033202
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K883460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 136524000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 01/31/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/01/2023; 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL2 NON COL HO SIZE 10; PINN MAR NEUT 50ODX32ID; PINNACLE 100 ACET CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male