MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remained implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00412.

Event Description

It was reported the patient was implanted with a reverse shoulder over a year ago.Subsequently, the patient was revised a couple of months ago due to the poly disengaging from the stem.

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.Insufficient information provided.Unable to perform a compatibility check.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 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 Description

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

• Brand Name: TM REVERSE STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9648764
• MDR Text Key: 177179013
• Report Number: 0001822565-2020-00411
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024268975
• UDI-Public: (01)00889024268975
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• 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: 00434901413
• Device Lot Number: 64141262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: UNKNOWN BASEPLATE PN: UNKNOWN LN: UNKNOWN; UNKNOWN GLENOSPHERE PN: UNKNOWN LN: UNKNOWN; UNKNOWN HUMERAL BEARING PN: UNKNOWN LN: UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention