MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIO-MOD HUM HEAD 40DIAX15MM; PROSTHESIS SHOULDER

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 12-113556, compr 6mm hum fract stem pps, lot # 339720.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2020-01547.Will be returned.

Event Description

It was reported that the initial operation was performed approximately a month ago.Subsequently, the head implant disassociated from the stem making the joint dislocated a week later with no pain.A revision was performed two (2) days afterward.

Event Description

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

Manufacturer Narrative

(b)(4).Updated: b4, b5, d10, g3, g4, h1, h2, h3, h6, h10.G3: japan reported event was considered confirmed from the x-rays which stated that the hardware was disassociated and that there is likely dislocation of the humerus and glenoid which is related to a fractured and disassembled component of the humerus hardware.Visual examination of the humeral head found scuffing on the outside radius and wear lines on the shaft.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: BIO-MOD HUM HEAD 40DIAX15MM
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9967233
• MDR Text Key: 187871452
• Report Number: 0001825034-2020-01546
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00887868253614
• UDI-Public: (01)00887868253614
• 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: 08/14/2020

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
• Device Catalogue Number: 113760
• Device Lot Number: 401330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/19/2020
• 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; Required Intervention
• Patient Age: 60 YR