MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US C-STEM AMT SZ4 HI OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	1570-14-100
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	10/30/2020
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
Removal of c-stem femoral implant and pinnacle head from a patient following a fall that resulted in a large spiral fracture of the femur.The fracture of the femur caused a the cement mantle to be opened and the stem to be malaligned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached image could not confirm the reported allegation.The root cause could not be determined.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 AMT SZ4 HI OFFSET
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10831593
• Report Number: 1818910-2020-24500
• Device Sequence Number: 2113426
• Product Code: JDI
• UDI-Device Identifier: 10603295060321
• UDI-Public: 10603295060321
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042959
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 1570-14-100
• Device Catalogue Number: 157014100
• Device Lot Number: D17080371
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: ARTICULEZE M HEAD 36MM +12; COMPETITOR CEMENT; ARTICULEZE M HEAD 36MM +12; COMPETITOR CEMENT
• Outcome Attributed to Adverse Event: Required Intervention