MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 40 MM DIAMETER; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Debris, Bone Shedding (1803); Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 00434901413, humeral stem 14 mm stem, lot # 62908449.Catalog #: 00434906606, retentive poly liner plus, lot # 03594043pe.Catalog #: 00434901500, base plate 15 mm post length uncemented, lot # 62926996.Visual examination of the provided pictures identified that all devices are explanted.Stem has bone tissue on the porous shaft.Poly liner is damaged on the bottom and has blood tissue.Glenosphere was explanted.On the x-rays is showed previous bone loss, ho, and instability.It also noted good position, no impingement, evidence stress shielding noted on the proximal anterolateral.Device history record 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00562, 0001822565-2020-00563.
Event or Problem Description
It was reported that the patient underwent an initial revision of the left shoulder due to instability.Subsequently patient experienced subluxation and underwent closed reduction, pain, instability and underwent a second revision due to liner disassociation.No additional information is available form the event.

• Brand Name: GLENOSPHERE 40 MM DIAMETER
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10212406
• Report Number: 0001822565-2020-02332
• Device Sequence Number: 2641173
• Product Code: HSD
• UDI-Device Identifier: 00889024269163
• UDI-Public: (01)00889024269163(17)311224(10)62859929
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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 Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00434904011
• Device Lot Number: 62859929
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 06/30/2020
• 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 Weight: 80