MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ D HI 70MM; PROSTHETIC, HIP

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Unequal Limb Length (4534)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01398.

Event Description

It was reported by pmi group that a custom hip needed for revision on unknown date.The surgeon wants to add an adapter to the current hip implant to correct the leg length discrepancy.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Once the investigation is completed, a supplemental mdr will be submitted.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

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.Lot identification is necessary for review of device history records, lot identification was not 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: ARCOS CON SZ D HI 70MM
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11783971
• MDR Text Key: 249263002
• Report Number: 0001825034-2021-01399
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM#11-300922 ARCOS 22X190MM SPL TPR DST LOT#UNK; UNKNOWN +3 CERAMIC HEAD; UNKNOWN 44 NEUTRAL LINER; UNKNOWN G7 MULTI HOLE SHELL; ITEM#11-300922 ARCOS 22X190MM SPL TPR DST LOT#UNK; UNKNOWN +3 CERAMIC HEAD; UNKNOWN 44 NEUTRAL LINER; UNKNOWN G7 MULTI HOLE SHELL
• Patient Outcome(s): Hospitalization; Required Intervention