• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX35MM BONE SCREWS AND PINS : SCREWS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX35MM BONE SCREWS AND PINS : SCREWS Back to Search Results
Catalog Number 121735500
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 03/13/2019
Event Type  Injury  
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 Description

It was reported that the liner disassociated from the cup. The locking ring came off from the liner as well. Doi: unknown - dor: (b)(6) 2019 (right hip).

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary ==> examination of the returned bone screw finds nothing outward to suggest a product problem. A worldwide complaint database search found no additional related reports against the provided product code/lot code combination. 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINN CAN BONE SCREW 6.5MMX35MM
Type of DeviceBONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-XXXX
6107428552
MDR Report Key8555634
MDR Text Key143256371
Report Number1818910-2019-91738
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK983014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121735500
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/26/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/26/2019 Patient Sequence Number: 1
-
-