MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DM UNIV PROV BRG 22.2 X 32MM; INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item #: unknown unknown head lot #: unknown.Item #: unknown unknown liner lot #: unknown.Item #: unknown unknown stem lot #: unknown.Item #: unknown unknown cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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 - 2020 - 00654 head.
Event or Problem Description
It has been reported the mobility trial came off of the femoral head and got stuck in the soft tissue in pelvis.It was successfully removed.Attempts were made to obtain additional information; however, none is available at this time.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed by visual examination of provide photograph.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.No product was returned the provided picture shows a g7 bearing provisional with no visible damage noted, no further evaluation can be performed using the provided photo.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 or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It has been reported (b)(6), was doing a trial reduction with our dual mobility trial and the dual mobility trial came off of the femoral head and got stuck in the soft tissue in pelvis.A general surgeon was call to remove the provisional.Surgery was delayed an hour.Attempts were made to obtain additional information; however, none was available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.

• Brand Name: DM UNIV PROV BRG 22.2 X 32MM
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9695766
• Report Number: 0001825034-2020-00653
• Device Sequence Number: 1877060
• Product Code: LXH
• UDI-Device Identifier: 00880304756939
• UDI-Public: (01)00880304756939
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2020

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: 110030153
• Device Lot Number: 978660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020; 06/11/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 02/13/2020; 06/11/2020
• 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: ITEM #: UNKNOWN UNKNOWN TRIAL HEADLOT #: UNKNOWN; SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 54