MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; EXTREMITY IMPLANT

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # j7300646; catalog #: 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 017740; catalog #: 110031399, mini tray std cocr +0 offset, lot # 65417969; catalog #: 110031419, cr prolong 36mm brng +3, lot # 64653505.G2: canada.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had an initial surgery approximately a year and a half ago.Subsequently, about 1 year later the patient was presented in ther clinic with shoulder pain.No trauma or pre existing conditions other than pain.X-rays revealed dislocation.Then about 1 month ago the patient underwent a revision for disassociation.During the revision surgery the glenosphere baseplate was stable.Glenosphere was disassociated.Humeral tray was intact.The bearing had significant wear.Glenosphere bearing humeral tray and glenosphere baseplate were all removed.The reverse shoulder was converted to a hemi construct.No further information available.

Manufacturer Narrative

(b)(4).Reported event was confirmed as visual examination of the returned product/provided pictures identified the item and lot number matches the taper adapter and the base plate.Product was not returned in original packaging.Taper adapter has damage to the taper and threads and base plate shows wear and damage, especially to the threaded area.Medical records/radiographs identified the following: implant fit is maintained.There is malalignment secondary to dislocation of the glenosphere from the glenoid baseplate.Bone quality appears osteopenic.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.

Event Description

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

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• 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: 18685684
• MDR Text Key: 335130677
• Report Number: 0001825034-2024-00362
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000589
• Device Lot Number: 880080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• 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: Female