MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COBALT CHROME HEAD; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Local Reaction (2035); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Concomitant medical products: unknown m2a cup.Unknown bimetric stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04036.0001825034-2020-04037.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to pain, difficulty ambulating, and adverse local tissue reaction approximately 7 years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

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.The event was confirmed with medical records received.Findings: six week visit denies pain.Still limps.Adequate rom.Limb lengths equal six month visit denies pain.Rarely/never limps.Adequate rom.Limb lengths equal one year visit denies pain.Rarely/never limps.Adequate rom.Limb lengths equal two year visit moderate - severe pain.Limping.Five year visit denies pain.Rarely/never limps.Adequate rom.Limb lengths equal ltfu revision due to armd (adverse reaction to metal debris) device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to 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 COBALT CHROME HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10812153
• MDR Text Key: 215468968
• Report Number: 0001825034-2020-04038
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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
• Device Catalogue Number: N/I
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 59