MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIO-MOD HUM HEAD 44DIAX17MM; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Pain (1994); Tissue Damage (2104); Non-union Bone Fracture (2369); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-113554 comp 4mm hum frac stem macro unknown; 113575 comp fx hum pos sleeve 7mm unknown; 414994 small dia cement plug 10mm unknown; unknown stryker implex cement.Report source- foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, hospital policy.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: 0001825034-2019-01653.

Event Description

It was reported that patient under went an initial shoulder hemiarthroplasty for a fractured shoulder and was subsequently revised due to pain, reduced range of motion due to non union, loosening and tendon tear one (1) year six (6) months post primary implantation.Surgeon noted superior glenoid wear and original fracture did not heal from the primary surgery.No additional information is available from the event.

Manufacturer Narrative

The following report is being submitted to relay additional information received: reported event was unable to be confirmed.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 additional information is available to report at this time.

• Brand Name: BIO-MOD HUM HEAD 44DIAX17MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8535570
• MDR Text Key: 142620178
• Report Number: 0001825034-2019-01654
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• 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: 113764
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2019
• 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
• Patient Age: 69 YR