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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: E-POLY 40MM +3 MAXROM LNR SZ24
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9608257
• Report Number: 0001825034-2020-00290
• Device Sequence Number: 10888467
• Product Code: OIY
• UDI-Device Identifier: 00880304469075
• UDI-Public: 00880304469075
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K100048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 95