MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4 PEG MOD GLEN SZ 2; PROSTHESIS, SHOULDER

Catalog Number	SAGL2042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Osteolysis (2377)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Modular post tm cat# sagp0002 lot# 64951711.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 00925.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 13 months postimplantion due to infection and bone loss.The implants were removed and a cement spacer was placed while a custom implant is being manufactured.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Corrected: h6 health effect previously stated 1930- unspecified infection and 1750- erosion.2377-osteolysis, 1994 ¿ pain, and 1870 - bone fracture(s) shall replace both prior codes.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 1 year post implantation due to progressive pain from prior revision.During the revision purulent cloudy fluid was encountered along with scar tissue, pseudocapsule, failure of subscapularis repair, mass with appearance of oyster mushroom, consistent with previous revision findings, osteolysis, loose cement, greater tuberosity periprosthetic fracture, and glenoid vault perforation.All implants removed with antibiotic spacer placed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: continued to have progressive shoulder pain.Preop diagnosis: failed right anatomic total shoulder arthroplasty, right subscapularis tendon rupture.X-ray; anterior subluxation of humerus consistent with subscapularis tendon failure.General with block.Deltopectoral approach with immediate purulent cloudy fluid and only a thin layer of scar tissue.¿the pectoralis muscle belly was completely scarred to the conjoined tendon, really allowing for no discernible tissue planes in this region.¿ pseudocapsule with purulent cloudy fluid, specimen sent to path.Right subscapularis tendon rupture, fiberwire sutures removed (not a new complaint due to disease progression).Large fungating masses coming out of the shoulder that had the appearance of oyster mushrooms and significant necrosis of soft tissue throughout glenohumeral joint, consistent with findings of with previous revision.Soft tissue excised throughout shoulder and sent to path/ osteolysis of glenoid component, loose cement removed, polyethylene cross hatched and removed in piecemeal fashion, weakening of glenoid vault, and post removed leaving a hole in the glenoid vault perforated which was ¿packed with gelfoam for hemostasis¿.Humeral component removed with slap hammer, greater tuberosity fracture at level of surgical neck related to significant osteolysis.Drain placed, immobilizer sling placed.Infectious disease doctor consulted, iv antibiotic x 6 weeks.Plan a 2nd stage revision for a reverse shoulder.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: 4 PEG MOD GLEN SZ 2
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13999187
• Report Number: 0001822565-2022-00924
• Device Sequence Number: 5657172
• Product Code: KWS
• UDI-Device Identifier: 00889024644762
• UDI-Public: (01)00889024644762(17)280804(10)64827338
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SAGL2042
• Device Lot Number: 64827338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 06/21/2022; 07/25/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 07/12/2022; 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female