MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US C-STEM SZ3; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Catalog Number	961163000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
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
It was reported that on (b)(6) 2014, the patient underwent a tha surgery for oa with the implants in question.After the surgery in (b)(6) 2024, x-rays showed no abnormalities in the liner in question.In (b)(6) 2025, ct scan revealed some wear (eccentricity of the head) movement behind the liner.On (b)(6) 2025, the patient visited the hospital complaining of abnormal noise and pain.An x-ray revealed significant displacement of the femoral head center.Dislocation and wear were suspected, but the x-ray findings did not reveal dislocation.The surgeon doubted that such extensive wear could occur in such a short period of time, and suspected liner dislocation.On (b)(6) a revision was scheduled for (b)(6) 2025.During the surgery, a sales representative checked the situation from the surgical field and confirmed the following: the liner at the top of the cup rim was embedded into the cup, with the anti-rotation tab destroyed.The delta head had collided with the cup rim and the tapered locking portion of the cup/liner (discolored due to friction with the head), causing significant damage.The surgeon determined that re-fixing the liners would be difficult, so all implants placed in the previous operation were removed and a complete revision was performed.The surgery was completed successfully with 30 minutes surgical delay.No further information is available.
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 that 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 recon described in this report.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: it was reported that on (b)(6) 2014, the patient underwent a tha surgery for oa with the implants in question.After the surgery in (b)(6) 2024, x-rays showed no abnormalities in the liner in question.In (b)(6) 2025, ct scan revealed some wear (eccentricity of the head) movement behind the liner.On (b)(6) 2025, the patient visited the hospital complaining of abnormal noise and pain.An x-ray revealed significant displacement of the femoral head center.Dislocation and wear were suspected, but the x-ray findings did not reveal dislocation.The surgeon doubted that such extensive wear could occur in such a short period of time, and suspected liner dislocation.On october 6th, a revision was scheduled for (b)(6) 2025.During the surgery, a sales representative checked the situation from the surgical field and confirmed the following: the liner at the top of the cup rim was embedded into the cup, with the anti-rotation tab destroyed.·the delta head had collided with the cup rim and the tapered locking portion of the cup/liner (discolored due to friction with the head), causing significant damage.The surgeon determined that re-fixing the liners would be difficult, so all implants placed in the previous operation were removed and a complete revision was performed.The surgery was completed successfully with 30 minutes surgical delay.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.C-stem sz3 only displays implantation and explanation sings.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the c-stem sz3 would have not contributed to the reported adverse 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 was performed for the finished device lot number d13102168, and no non-conformances / manufacturing irregularities were identified.Added: d10, h4.Corrected: h3.

• Brand Name: C-STEM SZ3
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 23450100
• Report Number: 1818910-2025-18848
• Device Sequence Number: 18134834
• Product Code: JDI
• UDI-Device Identifier: 10603295235200
• UDI-Public: (01)10603295235200(17)180930(10)D13102168
• 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: 2014
• 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,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 961163000
• Device Lot Number: D13102168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 01/27/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/26/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2013
• 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: APEX HOLE ELIM POSITIVE STOP; C-STEM SZ3; DELTA CER HEAD 9/10 28MM -3; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR ETO NEUT 28IDX48OD; PINNACLE SECTOR II CUP 48MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female