MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C STEM VOID CENTALIZER 10 DM; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Model Number	9612-10-500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 void centralizer was put onto the end of the c-stem implant before implanting and a noticeable audible crack was heard, the plastic centralizer had cracked.It¿s unclear if the void centralizer was put into the end of the c-stem with excessive force or not.The surgeon agreed to going up in size for the centralizer as there¿s only 1 set consigned at the hospital.The cracked plastic centralizer was discarded by the hospital as it is small and difficult to sterilize.Stickers for both centralizers were placed on the implant usage sheet.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 VOID CENTALIZER 10 DM
• Common Device Name: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11002994
• Report Number: 1818910-2020-26857
• Device Sequence Number: 3699360
• Product Code: JDI
• UDI-Device Identifier: 10603295235682
• UDI-Public: 10603295235682
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K013350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9612-10-500
• Device Catalogue Number: 961210500
• Device Lot Number: 9426841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1