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

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9967233
• Report Number: 0001825034-2020-01546
• Device Sequence Number: 2282426
• Product Code: HSD
• UDI-Device Identifier: 00887868253614
• UDI-Public: (01)00887868253614
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR