MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM CONSTR HD 36MM T1 STD; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 51-108080 tprlc 133, mp t1 pps so 8x101mm, 6006745.Pt-116056 regen/rnglc, ltd 56mm sz 24, 240160.11-107124 freedom all poly cup 54mm, 782430.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: 0001825034-2020-00315.
Event or Problem Description
A patient had revision right tha with cement spacers placed due to infection.Immediately postoperative it was noted that abduction was limited to about 20 degrees with impingement of the neck onto the acetabular component.Attempts were made to obtain additional information; however, none was available.
Additional Manufacturer Narrative
Udi #: (b)(4).Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.X-ray review indicates there is new cup was cemented and stable.Femur was drilled under c-arm intensification and then reamed due to bone status.Femoral component was impacted in the appropriate position & anteversion.Postop limb lengths were symmetrical, rom full flexion, abduction limited to about 20 degrees with impingement of the neck onto the acetabular component.This was with the leg in neutral.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.

• Brand Name: FREEDOM CONSTR HD 36MM T1 STD
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9608349
• Report Number: 0001825034-2020-00314
• Device Sequence Number: 16804802
• Product Code: KWZ
• UDI-Device Identifier: 00880304203464
• UDI-Public: 00880304203464
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 11-107018
• Device Lot Number: 395440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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
• Patient Weight: 95