MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PROTRUSIO CAGE 52OD X 49ID R; MISCELLANEOUS JOINT IMPLANTS : HIP ACETABULAR CAGES

Model Number	1011-71-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hematoma (1884); No Code Available (3191)
Date of Event	01/01/2017
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.No device associated with this report was received for examination.Review of the attached image found the device to be fractured.The root cause of the fracture 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.(b)(4).
Event or Problem Description
The literature article entitled, "the evolution of the cup-cage technique for major acetabular defects full and half cup-cage reconstruction" written by peter k.Sculco, md, cameron k.Ledford, md, arlen d.Hanssen, md, matthew p.Abdel, md and david g.Lewallen, md published by the journal of bone and joint surgery 2017 was reviewed.The article's purpose was to report on the results of utilizing cup-cage technique for major acetabular defects.Non-depuy acetabular shells were used in conjunction with depuy protrusio cages and non depuy joint reconstruction cages.Data was compiled from 57 cases.Table iii provides patient identifiers and adverse events but not identify if products involved were depuy or non depuy.Depuy product: protrusio cage.Adverse events: sciatic nerve injury (treated by reoperation) hematoma (treated by opeartive evacuation) cage/cup construct loosening (treated by revision - see figure 5a-5b) recurrent instability accompanied by dislocation (treated by revision).
Additional Manufacturer Narrative
Product complaint # (b)(4).Prior submission (mwr-(b)(4)) was submitted with the incorrect awareness date of 12-feb-2020.Correct awareness date 11-mar-2020.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PROTRUSIO CAGE 52OD X 49ID R
• Common Device Name: MISCELLANEOUS JOINT IMPLANTS : HIP ACETABULAR CAGES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9832126
• Report Number: 1818910-2020-07901
• Device Sequence Number: 2205000
• Product Code: JDJ
• UDI-Device Identifier: 10603295000532
• UDI-Public: 10603295000532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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 Expiration Date: 10/01/2018
• Device Model Number: 1011-71-000
• Device Catalogue Number: 101171000
• Device Lot Number: C5GBC1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention