MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOS MODULAR REVISION HIP SYSTEM BOWED INTERLOCKING DISTAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 09/22/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.(b)(4).This device is not cleared for distribution in the us; however, this report is being filed as zimmer biomet manufactures a similar device in the u.S.Under k090757.This report is number 2 of 4 mdrs filed for the same patient (reference 1825034-2016-04231, 04239, 04240, 04241).

Event Description

During a revision procedure, there was difficulty assembling the trial cone body on the distal stem.The proximal femur was reamed again and the trial cone body assembled correctly.Subsequently, the cone body became cold welded to the distal femoral stem.As a result, both components were removed.This event contributed to a 60 minute delay.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: arcos con sz b std 80 mm trl catalog#: 31-301342 lot#: 672230.Arcos 17 x 200 mm ils stem (17 x 200) and arcos cone size b standard 80 mm trial were returned for evaluation.The arcos cone body trial failed to disengage with arcos ils stem (17 x 200) during the surgery.Complaint is not confirmed as the parts were not cold-welded.Black debris is found inside the screw of the distal stem and also inside the threaded hole in the proximal part of the distal stem.This can be verified with the visual inspection.The ftir spectrum of the residue was found to be consistent with being of biological origin but could not determine the tissue.Bio debris has caused the components to seize.Presence of bio debris is due to improper cleaning of the distal stem taper junction prior to use.Device history record was reviewed and no discrepancies related with event were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause for the reported issue is found to be improper cleaning of the distal stem taper junction prior to trailing the proximal body 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 MODULAR REVISION HIP SYSTEM BOWED INTERLOCKING DISTAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6049076
• MDR Text Key: 58129269
• Report Number: 0001825034-2016-04239
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 22-301817
• Device Lot Number: 447850
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR