MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM SZ3; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	9611-63-000
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The primary surgery was performed about 15 years ago (the date was unknown) at another hospital via tha.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the stem due to the dislocation.The surgery was completed, and it was unknown whether there was any surgical delay.The surgeon found like corrosion on the removed stem.There was no loosening of the stem and cement, no sign of infection.The condition of fixation was good.The surgeon requested investigation of component analysis of corroded parts.No further information is available.
Event or Problem Description
Additional information received indicated that the removal of the stem was caused by the clear zones that were found at the bone/cement interface in the calcar section which cause pain to the patient.
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.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).Investigation summary: examination of the returned device and photographs confirmed the reported corrosion.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: C-STEM SZ3
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10876550
• Report Number: 1818910-2020-25113
• Device Sequence Number: 16803291
• Product Code: LZN
• UDI-Device Identifier: 10603295235200
• UDI-Public: 10603295235200
• 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 Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020

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 Model Number: 9611-63-000
• Device Catalogue Number: 961163000
• Device Lot Number: 1871038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 02/02/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/22/2020; 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention