MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY STD COCR +3 OFFSET; PROSTHESIS, EXTREMITIES

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); No Information (3190)
Date of Event	12/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item#113634; comp primary stem 14mm mini; lot# 300540, item# 110031424; cr vivacit-e 36mm brng std; lot# 64343846, item# 115310; comp rvrs shldr glnsp std 36mm; lot# 664970, item# 115395; comp rvs cntrl 6.5x25mm st/rst; lot# 139000, item# 180558; comp nlk scr 3.5hex 4.75x20 st; lot# 236640, item# 180552; comp lk scr 3.5hex 4.75x25 st; lot# 795520, item# 180551; comp lk scr 3.5hex 4.75x20 st; lot# 641130, item# 115330; comp rvrs shdr glen bsplt +ha; lot# 760180, item# 118001; versa-dial/comp ti std taper; lot# 349060.Report source: foreign: event happened in (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-05379.Remains implanted.
Event or Problem Description
It was reported patient suffered pain due to disassociated prosthesis approximately one month post-implantation.Due to short notice, replacement implants and instruments were not available.The surgeon reattached the glenosphere and humeral bearing to baseplate, used 2 juggerknots to help stabilize the shoulder.Two cerclage wires were attached to site.Patient will be observed to see how he does.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Correction: implant date is corrected.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a2; b4; b5; g4; g7; h1; h2; h3; h6 corrected: h4 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified separation of the glenosphere from the base plate of the reverse-type right shoulder arthroplasty and the humerus is slightly elevated in relation to the glenoid.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: MINI TRAY STD COCR +3 OFFSET
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9558399
• Report Number: 0001822565-2019-05380
• Device Sequence Number: 2578374
• Product Code: KWS
• UDI-Device Identifier: 00887868231346
• UDI-Public: (01)00887868231346
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031402
• Device Lot Number: 64327562
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/14/2020; 06/04/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/06/2020; 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR