MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIO-MOD GLEN 4MM ALL-POLY MED MM; PROSTHESIS, EXTREMITIES

Catalog Number	113851
Medical Device Problem Codes	Loss of Osseointegration (2408); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)
Date of Event	08/25/2010
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 - 01586.0001825034 - 2020 - 01588.0001825034 - 2020 - 01589.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported patient underwent right biomet comprehensive reverse shoulder system approximately ten (10) years ago.Patient underwent a revision procedure approximately three (3)months post-implantation due to pain, loss of range of motion and loosening.
Additional Manufacturer Narrative
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.Medical records were not provided.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.
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.D10: item# 118001; lot# 380310 item# 113646; lot# 453180 item# 113044; lot# 817890 item# 00111314001; lot# 68234202 item# 00111314001; lot# 69524228 item# 00111314001; lot# 69524228.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 the patient underwent a revision surgery approximately three (3) months post-implantation due to experiencing pain, loss of rom, and loosening of components.It was also noted that the patient was revised to a hemiarthroplasty due to anterior instability and loss of subscapularis.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: according to legal, the patient experienced pain, loss of range of motion, and loosening of components.Revision to hemiarthroplasty due to anterior instability and loss of the subscap.The root cause of the previous revision does not change.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIO-MOD GLEN 4MM ALL-POLY MED MM
• Common Device Name: PROSTHESIS, EXTREMITIES
• 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: 9943725
• Report Number: 0001825034-2020-01585
• Device Sequence Number: 16964710
• Product Code: KWT
• UDI-Device Identifier: 00880304006928
• UDI-Public: (01)00880304006928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2024

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: 04/28/2012
• Device Catalogue Number: 113851
• Device Lot Number: 616490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 03/07/2024; 08/09/2024
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 04/24/2020; 03/19/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2007
• 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
• 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 Sex: Female