MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOSTOP G CEM RESTR 12MM; DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG

Model Number	5463-12-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	09/16/2019
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
Revision reverse total shoulder: (b)(6) hospital, (b)(6) 2019.This was the 2nd revision on this patient due to chronic dislocation.Primary implant done in 2017 and first revision in mid-2018.Original case was a fractured humerus, and the first revision was done due to dislocation.The patient ended up after first revision with spacer plus 38/9 poly.The surgeon said patient had fallen again and required re revision.The original plan was to convert to hemi with a cta head as he thought the glenoid components would be loose, but after opening the base plate was secure so he upsized the head to a 42 and put in a 6 standard poly and it wasn't dislocating at all.The surgeon said revision had nothing to do with the implant, he felt the patient had deltoid insufficiency and had severe infection issues for many years.Female patient, initial: r., dob: (b)(6) 1950.
Additional Manufacturer Narrative
Product complaint # (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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.Product complaint # (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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BIOSTOP G CEM RESTR 12MM
• Common Device Name: DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9166364
• Report Number: 1818910-2019-108307
• Device Sequence Number: 11673414
• Product Code: JDK
• UDI-Device Identifier: 10603295174561
• UDI-Public: 10603295174561
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K943727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2019

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 Model Number: 5463-12-000
• Device Catalogue Number: 546312000
• Device Lot Number: 16E3103005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 03/20/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/09/2019; 04/10/2020
• 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
• Patient Age: 69 YR