MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR 10MM HUM FRACT STEM PPS; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog #: unknown, humeral head, lot # unknown; catalog #: unknown, taper adapter, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03449, 0001825034-2020-03450.Will not be returned.

Event Description

It was reported that a revision occurred for an unknown reason where the stem was taken out and a reverse shoulder was place.Attempts have been made and there is no additional information available at this time.

Event Description

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

Manufacturer Narrative

Cmp-(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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.

• Brand Name: COMPR 10MM HUM FRACT STEM PPS
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10494351
• MDR Text Key: 205684844
• Report Number: 0001825034-2020-03408
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304591564
• UDI-Public: (01)00880304591564(17)290515(10)224410
• Combination Product (y/n): N
• PMA/PMN Number: K140652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 12-113560
• Device Lot Number: 224410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• 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