MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CANCELLOUS BONE SCREW 6.5X15MM; BONE SCREWS AND PINS : SCREWS

Catalog Number	117215000
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Der stated that primary tha was done in 2003 (exact date unknown).Head-on automobile collision in (b)(6) 2017 led to chronic dislocation of implant, requiring acetabular revision.Cup, liner, and head were revised.Cup was loose at the bone to implant interface.Doi: 2003; dor (b)(6) 2018; right hip.No surgical delay.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CANCELLOUS BONE SCREW 6.5X15MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7507598
• Report Number: 1818910-2018-59431
• Device Sequence Number: 16588235
• Product Code: HWC
• UDI-Device Identifier: 10603295007593
• UDI-Public: 10603295007593
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K970929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 117215000
• Device Lot Number: V2LBP4059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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
• Patient Age: 68 YR
• Patient Weight: 100