MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM +3 MAXROM LNR SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product(s: 650-1064 cer option type 1 tpr sleve -6 2914167; 650-1058 cer bioloxd option hd 40mm 2904573; pt-116056 regen/rnglc+ ltd 56mm sz 24 240160; 51-108080 tprlc 133 mp t1 pps so 8x101mm 6006745.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent right total hip arthroplasty and subsequently was revised three months later due dislocation.The head and liner components were removed and replaced.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

Udi #: (b)(4).Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.X-ray review indicates there is history of anterior dislocation noted on april 22, 2018.61 year old male has a history of total hip arthroplasty.The patient had initial dislocations after surgery.He was treated with open reduction and placement of a (constrained) liner.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.

• Brand Name: E-POLY 40MM +3 MAXROM LNR SZ24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9608257
• MDR Text Key: 187617213
• Report Number: 0001825034-2020-00290
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304469075
• UDI-Public: 00880304469075
• Combination Product (y/n): N
• PMA/PMN Number: K100048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

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 Expiration Date: 02/08/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-108424
• Device Lot Number: 538330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 04/30/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 95