MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOSPHERE; EXTREMITY IMPLANT

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: catalog#: 211241, compr srs mod stem - 6x150mm, lot#: 11771922.Catalog#: 211216, compr srs prox bdy - sm 58mm, lot#: 261100.Catalog#: 211228, compr srs mod rgx aug - sm, lot#: 209220.Catalog#: 211225, compr srs ic seg - 60mm, lot#: 936310.Catalog#: unknown, cement, lot#: unknown.Catalog#: unknown, bearing, lot#: unknown.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02758.H3 other text: not returned.

Event Description

It was reported a patient, with metastatic bone disease, had a left reverse total shoulder arthroplasty on approximately 3 years ago.Subsequently, about 6 months later, the patient underwent a revision of the stem due to dislocation.The patient was withdrawn from the study and no additional information has been provided.Attempts have been made and there is no further information at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Proposed annex g code: mechanical (g04) - head.Reported event was confirmed by radiograph review.Medical records/radiographs identified the following: implant fit is maintained.Initial alignment was anatomic but 6 month images demonstrate a dislocation of the reverse-type arthroplasty.Bone quality is osteopenic on all images.There is no evidence of loosening or other abnormality.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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: UNKNOWN GLENOSPHERE
• Type of Device: EXTREMITY IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18193823
• MDR Text Key: 328821431
• Report Number: 0001825034-2023-02757
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 122 KG