MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 16 MM STEM DIAMETER; PROSTHESIS, EXTREMITIES

Catalog Number	00434901613
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Discomfort (2330)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-01072.Device product code - phx.Concomitant medical devices: part# 00434904003; lot# 63319394; part# 00434901500; lot# unk; part# 00434904011; lot# unk; part# unk stem; lot# unk; part# unk screw; lot# unk; part# unk screw; lot# unk.Full establishment name - (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: poly had disassociated from the tray.Axillary nerve was encased in scar tissue and being pulled with rom of the shoulder.Complete release of the axillary nerve was performed freeing up the nerve, completing axillary nerve decompression.Release of the subscapularis, capslotomy off the inferior glenoid neck.Removal of the glenosphere which was severely scratched.Subscapularis tendon transfer to greater turberosity.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is abnormal alignment with subluxation/dislocation of the reverse type left shoulder arthroplasty with slight proximal and lateral position of the humeral tray in relation to the glenosphere.No fracture is identified.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
It was reported that a patient underwent an initial procedure approximately one (1) year and four (4) months ago.Subsequently, the patient was revised approximately one (1) month post-implantation due to pain and discomfort.During surgery, it was discovered that the poly had disassociated from the humeral tray and the glenosphere was severely scratched.Attempts have been made and no further information has been provided.

• Brand Name: HUMERAL STEM 16 MM STEM DIAMETER
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11671403
• Report Number: 0001822565-2021-01073
• Device Sequence Number: 19682180
• Product Code: PHX
• UDI-Device Identifier: 00889024269002
• UDI-Public: (01)00889024269002
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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 Catalogue Number: 00434901613
• Device Lot Number: 64141291
• 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: 05/20/2020
• Initial Report FDA Received Date: 04/15/2021
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR