MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ARCOS CONE; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Malposition of Device (2616); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Ambulation Difficulties (2544)

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: united kingdom.Product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -00611 and 0001825034 -2023 -00612.Citation: kendrick, b.(2023).Post-market clinical follow-up study to provide safety, performance and clinical benefits data of the arcos modular revision femoral porous coated stem (implants and instrumentation) ¿ a retrospective and prospective consecutive series study [review of post-market clinical follow-up study to provide safety, performance and clinical benefits data of the arcos modular revision femoral porous coated stem (implants and instrumentation) ¿ a retrospective and prospective consecutive series study].Mdrg2017-89ms-95h(revision 0.2).

Event Description

It was reported in a clinical study that one (1) patient was revised due to malignment, instability and wear approximately 5.2 years post op.The stem was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.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: UNKNOWN ARCOS CONE
• Type of Device: 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: 16600315
• MDR Text Key: 311946131
• Report Number: 0001825034-2023-00610
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK ARCOS STEM.; UNK CUP.; UNK HEAD.; UNK LINER.
• Patient Outcome(s): Hospitalization; Required Intervention