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

Catalog Number	XL-115363
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteolysis (2377); Osteopenia/ Osteoporosis (2651)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00734.0001825034-2020-00795.Customer is indicated to be revised, but revision surgery date has yet to be scheduled.Concomitant medical products: part #115330 lot #524630.Part #115384 lot #364490.Part #180509 lot #211690.Part #180509 lot #442880.Part #180510 lot #918970.Part #180510 lot #918970.Part #417200 lot #0000633939.Part #402439 lot #628120.Part #402439 lot #632240.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Mmi review of xrays had significant findings of loosening, dislocation, osteopenia, radiolucency, and osteolysis.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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
It has been reported patient underwent right reverse shoulder arthroplasty 9 years ago.Subsequently patient is indicated to be revised due to dislocation, loosening, and migration, but surgery has yet to be scheduled.
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: b4; b5; g4; g7; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the humeral implant of the right shoulder arthroplasty is loose and the implant is proximally displaced with dislocation of the prosthetic joint.There has been apparent resection of a portion of the proximal humerus related to tumor excision as described.Lucency is noted along the humeral implant margins consistent with osteolysis.Osseous fragments of uncertain age are present inferior to the glenosphere and medial to the proximal humerus.The bones are osteopenic.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

• 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: 9727099
• Report Number: 0001825034-2020-00733
• Device Sequence Number: 16644580
• Product Code: KWS
• UDI-Device Identifier: 00880304475427
• UDI-Public: (01)00880304475427
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: 08/28/2016
• Device Catalogue Number: XL-115363
• Device Lot Number: 231090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 07/23/2020
• 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: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR