MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ E STD 80MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 11-301021 arcos stem 753680; 650-1055 bioloxd option hd 428120; 650-1066 tpr sleve 779450; 87-3435 depuy liner 7930873; unknown, unknown cup unknown; 298.801.01s depuy cable 1.7mm p314617; 298.801.01s depuy cable 1.7mm p314617; 298.801.01s depuy cable 1.7mm p314617; 298.801.01s depuy cable 1.7mm p310298; 298.801.01s depuy cable 1.7mm p313427; 1622022-1001 lifenet cortical strut unknown; 1619380-1000 lifenet cortical strut unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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 - 2021 - 00463.

Event Description

It was reported that the patient underwent a left tha on an unknown date.The patient was revised several times.The patients' legal attorney claims that the patient continues to suffer from pain, lost mobility and a leg length discrepancy as a result of the last revision surgery.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A definitive root cause cannot be determined, however a competitor liner was implanted during the revision in 2013 and this would be a incompatible device, it is unknown if this compatibility issue would of caused or contributed to the events.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: ARCOS CON SZ E STD 80MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11321102
• MDR Text Key: 231587567
• Report Number: 0001825034-2021-00464
• 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: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 11-301345
• Device Lot Number: 175530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR