MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 C-STEM SZ7; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Catalog Number	961167000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
This pc is related to (b)(4) which reports the cause of the revision surgery.This pc reports the poor fit of the stem found during the revision surgery.It was reported that on (b)(6) 2008, the patient underwent an initial surgery performed with the implants in question.The surgery was completed successfully with no surgical delay.After the surgery on (b)(6) 2025, a femoral head dislocation was confirmed.On (b)(6) 2025, the revision surgery was performed to replace the liner and head.During the surgery, an acetabular cup, polo product reported on (b)(4), loosening was confirmed and the cup was replaced with a cement cup from other company.When the head was replaced with a new 9/10 taper head, it was found that the neck taper was distorted and there was a poor fit, which may have been the cause of the dislocation, so the stem was removed and replaced with a new cemented stem (c-stem amt).The surgery was completed successfully with no surgical delay.After the surgery, the surgeon concluded that the reason for the cup revision was that black tissue had formed at the boundary surface, which had caused bone dissolution and loosening.The reason for the stem revision was that, just as the femoral head had dislodged when the malfunction occurred, even when a new 9/10 head was installed, there was a poor fit, so the surgeon considered it impossible to stay the stem, and so it was removed and replaced with a new stem.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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: C-STEM SZ7
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22564654
• Report Number: 1818910-2025-12610
• Device Sequence Number: 15760326
• Product Code: JDI
• UDI-Device Identifier: 10603295235248
• UDI-Public: (01)10603295235248(17)110330(10)2131864
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2025
• 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

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2011
• Device Catalogue Number: 961167000
• Device Lot Number: 2131864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2006
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 85 KG