MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE ANT BDY 128 SZ6/8; MISC EXTREMITY IMPLANT

Catalog Number	110020010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Synovitis (2094); Tissue Damage (2104)
Date of Event	06/15/2017
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
Second revision of a broken global unite head planned for (b)(6) 2017.First revision occurred on (b)(6) 2017 for the exact same issue.The surgeon will implant a reverse prosthesis.Update 7-31-2017: translated medical records (b)(6) 2017 have been reviewed.Operative note indicates the patient received a revision left total shoulder through reversal of entire prosthesis and synovectomy due to disassembly of prosthetic head through humeral prosthesis of the left shoulder.The surgeon notes synovial hypertrophy with numerous metal inclusions at the lower part of the subscapularis.He also notes that the prosthesis head has disassembled from the metaphyseal morse taper and is loose in the joint.He notes synovial hypertrophy with metallosis, prevailing on the glenoid side.Please note, the humeral head was initially reported as broken/fractured, however, the medical records indicate it became disassembled from the humeral prosthesis, not fractured.Updated on 8-15-2017.
Additional Manufacturer Narrative
Investigation summary : investigation of the reported event confirmed the reported device disassociation.Depuy synthes 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.

• Brand Name: GLOBAL UNITE ANT BDY 128 SZ6/8
• Common Device Name: MISC EXTREMITY IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6829957
• Report Number: 1818910-2017-23700
• Device Sequence Number: 10778230
• Product Code: HSD
• UDI-Device Identifier: 10603295433224
• UDI-Public: 10603295433224
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2017

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: 110020010
• Device Lot Number: 8177711010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 05/01/2018
• 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: 62 YR
• Patient Weight: 40