MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X44MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); No Information (3190)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that approximately 3 months post implantation the patient underwent a revision procedure due to the sound of grinding of the hip, pain, and limited range of motion.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported the patient underwent a primary right tha.Subsequently patient reported grinding, pain and limited rom with mobility.Revision of right tha head/dual mobility bearing was then performed.Surgeon noted, metallosis stained tissue, subluxation occurring, with noted wear and deformity of implant.No additional information.

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.D4: udi#: (b)(4).The event was confirmed with product received.Upon visual inspection there were scratches and indentations to the outer profile of the device.The underside has been deformed and the seating location is oblong rather than a circle.Due to damage no further testing was completed.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

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.Complaint sample was evaluated and the reported event was confirmed.One act artic e1 hip brg 28x44mm was returned and evaluated.Upon visual inspection there were scratches and indentations to the outer profile of the device.The underside has been deformed and the seating location is oblong rather than a circle.Due to damage no further testing was completed.Device history record (dhr) was reviewed and no discrepancies were found.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: ACT ARTIC E1 HIP BRG 28X44MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10097516
• MDR Text Key: 194102704
• Report Number: 0001825034-2020-02147
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• 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: EP-200150
• Device Lot Number: 805600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT# 00877502803 BIOLOX HEAD LOT# 2986097; UNK LINER.; UNK SHELL.; UNK STEM.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR