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

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was requested but not returned by hospital.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.Concomitant products: part # unknown / 16x250 interlocking stem/ lot # unknown.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -03452.

Event Description

It was reported that patient underwent a hip revision surgery due to stem subsidence.The surgery involved an extended trochanteric osteotomy and bone graft.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined this component did not contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined this component did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN ARCOS STEM BODY
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12912942
• MDR Text Key: 281573146
• Report Number: 0001822565-2021-03453
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 87 KG