MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 BIOSTOP G CEM RESTR 18MM; DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG

Catalog Number	546318000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
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
We had a total hip replacement (thr) and it was complicated at the moment of adding the final piece, the impactor broke.The screws were tried to be placed but it did not have a good grip because the patient had osteoporosis.And for that reason they cemented the liners.And when he was placing the biostop 18 it broke off and could not place it and placed another measure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Examination of the attached photograph confirmed the reported event.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).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: BIOSTOP G CEM RESTR 18MM
• Common Device Name: DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw 46582
• MDR Report Key: 8949493
• Report Number: 1818910-2019-102613
• Device Sequence Number: 2562350
• Product Code: JDK
• UDI-Device Identifier: 10603295174592
• UDI-Public: 10603295174592
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: No Information
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 546318000
• Device Lot Number: 18C1501008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR