MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS LATERAL TROCH BOLT 30MM; PROSTHESIS, HIP

Catalog Number	11-302130
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a hip revision approximately one month post implantation due to a loose claw, bolt and wires.The stem, head and cup remain implanted.The loose parts were removed and a plate was installed on the lateral side to secure fixation.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat #: 11-302101 / arcos troch claw large 100mm / lot #: 65688621.Unknown wire x 2.G2: switzerland.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-01065.This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Impressions: right total hip arthroplasty with interval loosening of the lateral claw secondary to rotation of the greater trochanter.The event was confirmed based on the evaluation of the provided medical records.Dhr was reviewed and no discrepancies related to the reported event were found.The root cause of the reported issue is attributed to off-label use of the claw and threaded bolt, per page 19 of the arcos broach surgical technique 0530.2-glbl-en "once the trochanteric fixation option has been determined, compress the auxiliary implant to the bone fragment by threading the plunger tightly against the auxiliary implant using the 5.0 mm hex driver and t-handle in the torque limiting position".As noted in the complaint description a large claw was fixed with 1 bolt, and 2 wires distally, however no proximal fixation since there was no lesser trochanter for wire fixation.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 additional event information to report at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The root cause of the reported issue is attributed to off label use of the claw and threaded bolt.Per ifu (instructions for use), ¿tight fixation of all non-cemented components at the time of surgery is critical to the success of the procedure.Each component must properly press fit into the host bone which necessitates precise operative technique and the use of specified instruments.Bone stock of adequate quality must be present and appraised at the time of surgery.¿ additionally, the surgical technique states "the arcos modular femoral revision system is not designed for use in a fully unsupported proximal femur.Bone stock of adequate quality must be present and appraised at the time of surgery." as reported, the claw was fixed with 1 bolt and 2 wires distally, however no proximal fixation with a cable was present since there was no lesser trochanter for wire fixation, indicating that there was not adequate bone stock present and tight fixation of these non-cemented components could not be achieved.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 LATERAL TROCH BOLT 30MM
• 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: 19174125
• Report Number: 0001825034-2024-01066
• Device Sequence Number: 7330863
• Product Code: KWA
• UDI-Device Identifier: 00880304474345
• UDI-Public: (01)00880304474345(17)270407(10)760420
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090757
• 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,Followup
• Report Date (Section B): 10/14/2024

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 Catalogue Number: 11-302130
• Device Lot Number: 760420
• 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: 04/14/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 10/10/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 09/24/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown