MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 110024464 729640 g7 dual mobility liner 44mm f; 110031012 65055299 vivacit-e dm bearing 28x44mm; 650-1159 3073375 delta cer fem hd 28/-3mm t1; 11-300814 820590 arcos 14x150mm spl tpr dist; 00877503602 3044108 biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient was revised approximately 6 months post implantation due to loosening of the femoral stem.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6.Reported event was confirmed by review of medical records received.Review of the available records identified a right tha was performed.The patient began reporting pain and declining function with lucencies observed around the stem.A revision was performed where the stem was found to be loose.The liner, stem, and head were explanted, and zimmer products were placed.Limb lengths were restored.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: FEMORAL STEM 12/14 NECK TAPER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12894203
• Report Number: 0001822565-2021-03354
• Device Sequence Number: 3459257
• Product Code: LPH
• UDI-Device Identifier: 00889024131842
• UDI-Public: (01)00889024131842(17)300928(10)64670372
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K032726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: 00771101120
• Device Lot Number: 64670372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Weight: 88 KG