MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 8X75MM; PROSTHESIS, SHOULDER

Catalog Number	211231
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Information (3190)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: compr srs prox bdy - lg 62mm cat# 211220 lot# 747200.Versa-dial 38x19x39 hum head cat# 113022 lot# 692250.Versa-dial/comp ti std taper cat# 118001 lot# 319860.Compr srs ic seg - 60mm cat# 211225 lot# 684190.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.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
Event or Problem Description
It was reported that patient underwent total shoulder arthroplasty.Subsequently, the patient requires a revision due to loosening and limb length discrepancy, but revision has yet to occur.The surgeon has requested a humeral expandable to reconstruct the humeral bone.Patient is still growing, and the surgeon believes an expandable device would help limit the total number of surgeries required for the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that the patient underwent a revision approximately 13 months after initial procedure.The custom device that was specially developed could not be used due to an abnormality with the patient's autograft.Instead, the surgeon decided to use a static srs humeral component to finish the procedure.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b3, b4, b5, d7, g4, g7, h2, h10.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: very limited imaging is provided.Osseous gap within the humerus along the right shoulder arthroplasty humeral stem and lucency along the stem suggesting loosening.Additional information does not change the root cause of the previous investigation.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: COMPR SRS MOD STEM - 8X75MM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10814245
• Report Number: 0001825034-2020-04024
• Device Sequence Number: 16625915
• Product Code: KWT
• UDI-Device Identifier: 00880304540583
• UDI-Public: (01)00880304540583(17)280722(10)043430
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2021

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: 211231
• Device Lot Number: 043430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 05/17/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/04/2021; 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 11 YR