MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 113632, comprehensive primary stem, 317190.113954, comprehensive hybrid glenoid, 458020.113044, comprehensive humeral head, 351910.113954, comprehensive hybrid glenoid, 458020.Customer has been 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 - 10036, 0001825034 - 2017 - 10038.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty procedure.Subsequently, it was reported that the patient was not doing well due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (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.Review of the x-rays identified that there was right shoulder arthroplasty with glenoid component containing a central peg which demonstrates radiolucency along the proximal aspect of the peg.There was no significant radiolucency along the remainder of the central peg.Humeral component appeared to be adequately placed without significant radiolucency.Ossific density along the posterior glenoid on the axillary film may represent a loose body.It was also noted there was mild ac joint degenerative change and osteopenia within the glenoid and proximal humerus.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: COMPREHENSIVE HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7014577
• MDR Text Key: 91501216
• Report Number: 0001825034-2017-10037
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 113044
• Device Lot Number: 351910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2010
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 84 YR
• Patient Weight: 60