MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO BI-METRIC POR FMRL NC 11X135MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Five days post op, the patient developed pain and was unable to bear weight.The patient had no trauma or falls post initial surgery.A secondary x-rays showed that the stem had subsided.Subsequently, the patient underwent a revision procedure approximately 2 weeks post implantation.During the secondary procedure, a fracture was found, cabled and a bigger stem was reamed, broached, and inserted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 163670 lot# j7252771 32mm mod head cocr +3mm neck.Cat# 010000664 lot# 7586906 g7 pps ltd acet shell 54f.Cat# 010000928 lot# 7273204 g7 hi-wall e1 liner 32mm f.G2: foreign: new zealand.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.The surgeon is unsure of when the bone fracture occurred, during the initial placement or sometime before the revision.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 information at the time of this report.

• Brand Name: ECHO BI-METRIC POR FMRL NC 11X135MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19012190
• Report Number: 0001825034-2024-00867
• Device Sequence Number: 7981562
• Product Code: KWA
• UDI-Device Identifier: 00887868260421
• UDI-Public: (01)00887868260421(17)321212(10)387520
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K070274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: 192011
• Device Lot Number: 387520
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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