MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TAPER ADAPTOR; PROSTHESIS, EXTREMITY

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).Multiple mdrs were filed for this event.Please see associated: 0001822565-2019-03821, 0001822565-2019-03822.Concomitant medical products: unknown part, lot- screw, baseplate, taper adaptor.Report source: foreign; event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by manufacturer.

Event Description

It was reported the patient was revised to address glenosphere disassociation attributed to screw back out in-vivo.No further information has been made available at the time of this reporting.

Manufacturer Narrative

Reported event was unable to be confirmed as no device was returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 information has been made available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

No further information has been made available at the time of this reporting.

• Brand Name: UNKNOWN TAPER ADAPTOR
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8979289
• MDR Text Key: 157039583
• Report Number: 0001822565-2019-03820
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 09/11/2019; 11/01/2019
• Supplement Dates FDA Received: 09/13/2019; 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention