MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS TAPER DISASMBLY 60MM; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the surgery, the disassembly tool would not disengage from the stem.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 31-301890 lot# zb171101 arcos 90 deg stem extractor.G2: foreign: switzerland.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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.The following sections were {update/corrected}.The root cause for the issues reported with the taper disassembly and stem is attributed to user error.As per ifu and surgical technique must be followed.For the arcos modular femoral revision system - cone proximal body surgical technique "when disengaging the taper junction within the femur the proximal body may feel tight within the bone although the taper junction is disengaged.This is due to the initial fixation of the pps coating to the bone.Gently tap the underside of the taper disassembly tool with the mallet to extract the proximal body from the bone.Do not continue tightening the torque wrench as this may damage the implant." based on the thread damage on the taper disassembly and stem, this indicates that the user continued threading the tool into the implant after the tapers were disengaged.The complaint is confirmed based on the returned product evaluation.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.
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; d9; g3; h2; h3; h4; h6.One arcos taper disasmbly 60mm was returned and evaluated.Upon visual inspection the taper assembly was returned inside of the body.There was no visible damage to the exposed threads.The shaft of the device showed some scuffing inside of the female taper.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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 TAPER DISASMBLY 60MM
• Common Device Name: INSTRUMENT, 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: 19483107
• Report Number: 0001825034-2024-01505
• Device Sequence Number: 18161245
• Product Code: HTO
• UDI-Device Identifier: 00880304484504
• UDI-Public: (01)00880304484504(11)180721(10)ZB180101
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/12/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-301857
• Device Lot Number: ZB180101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/02/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 12/12/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 11/22/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female