MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 70MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Scar Tissue (2060); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02494.G2: foreign: canada.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.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty.Subsequently, the patient was revised for a second time approximately 13 years later due to unknown reasons.An extended trochanteric osteotomy was required to remove the well-fixed stem which also resulted in femoral fracture requiring an open reduction internal fixation.Attempts have been made no andfurther information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint confirmed based one medical records evaluation.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: previous intraoperative fracture and planned osteotomy during stem revision, thin bone.A definitive root cause cannot 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty.Subsequently, the patient was revised for a second time approximately 13 years later due to metal related pathology.An extended trochanteric osteotomy was required to remove the well-fixed stem which also resulted in femoral fracture requiring an open reduction internal fixation to fixate the greater trochanter to the femur.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: b5; d1; d2; d4; g3; g4; h2; h6.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty.Subsequently, the patient was revised for a second time approximately 13 years later due to metal related pathology.An extended trochanteric osteotomy was required to remove the well-fixed stem which also resulted in femoral fracture requiring an open reduction internal fixation to fixate the greater trochanter to the femur.During the procedure, a fracture fragment of the greater trochanter was highly comminuted with thickening and fibrosis.A broken unknown cerclage wire was removed, the nonunion was reduced, and a greater trochanteric claw plate with cables was placed satisfactorily.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}; updated: d4; g3; h2; h3; h4; h6.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: xray findings of resorption of osteotomy fragment laterally with gt escape, fracture of greater trochanter and some resorption of bone across the lateral aspect of hip.The fracture remains unmoved.Fragment was highly comminuted with thickening and fibrosis of much of the tissue.Fibrous nonunion between the fracture fragments was then cleared to allow appropriate reduction.A definitive root cause cannot 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: ARCOS CON SZ A STD 70MM
• 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: 18072699
• Report Number: 0001825034-2023-02495
• Device Sequence Number: 6520252
• Product Code: KWA
• UDI-Device Identifier: 00880304474314
• UDI-Public: (01)00880304474314(17)281028(10)054830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301321
• Device Lot Number: 054830
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 11/13/2023; 05/28/2024; 06/13/2024; 07/09/2024; 11/05/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/16/2023; 06/20/2024; 06/27/2024; 07/16/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2018
• 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: Female
• Patient Weight: 55 KG
• Patient Race: White