MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR NANO HMRL PPS 32MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 118001, versa-dial/comp ti std taper, 079030.113032, versa-dial 42x18x46 hum head, 947100.113952, sm hybrid glenoid base 4mm, 817120.Pt-113950, pt hybrid glen post regenerex, 376020.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 - 2017 - 11325, 0001825034 - 2017 - 11327, 0001825034 - 2017 - 11328, 0001825034 - 2017 - 11329.

Event Description

It was reported that the patient underwent shoulder surgery.Subsequently, the patient is experiencing pain and instability in the operative shoulder.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.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

Upon reassessment of the reported event, it was determined to not be reportable as we do not have reporting responsibility for this complaint.The initial report was submitted in error and should be voided.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined to not be reportable as we do not have reporting responsibility for this complaint.The initial report was submitted in error and should be voided.

• Brand Name: COMPR NANO HMRL PPS 32MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7133864
• MDR Text Key: 95359249
• Report Number: 0001825034-2017-11326
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/14/2023
• Device Model Number: N/A
• Device Catalogue Number: US-115732
• Device Lot Number: 402810
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR
• Patient Weight: 61