MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR MD; SHOULDER/PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01243, 0001825034-2021-01244, 0001825034-2021-01245, 0001825034-2021-01246.Medical products: item#: 115396, comp rvs cntrl 6.5x30mm st/rst; lot#: 071250; item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 568750; item#: 180560, comp nlk scr 3.5hex 4.75x30 st; lot#: 109940; item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 553500; item#: 113057, versa-dial 50x27x50 hum head; lot#: 886670; item#: 118001, versa-dial/comp ti std taper; lot#: 277440; item#: 113630, comp primary stem 10mm mini; lot#: 64548820.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product was discarded by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a left shoulder revision surgery approximately three (3) weeks ago while during a revision surgery for unknown reason surgeon was trialing the base plate came out along with glenosphere.It was reported by the surgeon that the patient's bone was soft and that the revision was then converted to a hemiarthroplasty.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01243-1 0001825034-2021-01244-1 0001825034-2021-01245-1 0001825034-2021-01246-1 the following sections were updated: b4; b5; g3; g6; h1; h2; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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: COMP AUG MINI BSPLT W TPR MD
• Common Device Name: SHOULDER/PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12134277
• Report Number: 0001825034-2021-01996
• Device Sequence Number: 14529078
• Product Code: KWS
• UDI-Device Identifier: 00880304993242
• UDI-Public: (01)00880304993242(17)280918(10)64180837
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 110032420
• Device Lot Number: 64180837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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