MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 STD HMRL BRNG; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Medical product: catalog #: 115375, comp rvs tray +5mm co 44mm, lot # 703690.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it the hospital would not return.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: 0001825034-2021-01959.
Event or Problem Description
It was reported that a patient underwent a reverse shoulder replacement for a right proximal humeral fracture.Patient also had a contra lateral humeral shaft fracture.The reverse shoulder replacement dislocated and an attempt at a close reduction carried out.Patient did not improve, therefore decision to take back to theatre for revision.During revision case it was noted that the humeral tray had disengaged from the stem.This was not shown on original x-ray therefore the consultant is now querying whether the tray disengaging from the stem occurred during the closed reduction attempt.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: unknown, stem, lot # unknown.Catalog #: unknown, glenosphere, lot # unknown.Reported event was unable to be confirmed as visual examination of the provided picture identified the tray and bearing were assembled together.No obvious damage could be seen.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: 0001825034-2021-02722, 0001825034-2021-02723.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12100635
• Report Number: 0001825034-2021-01960
• Device Sequence Number: 3577589
• Product Code: KWS
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427(17)241211(10)620260
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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 Expiration Date: 12/11/2024
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 620260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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