MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIV SLD/APX HLE SHL 60MM SZ25; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Reaction (2414); No Information (3190)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) multiple mdr's were submitted for this event.Please see report(s): 0001825034-2018-00546, 0001825034-2018-00548.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient was revised to address polyethylene liner fracture and metallosis.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.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: UNIV SLD/APX HLE SHL 60MM SZ25
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7245303
• MDR Text Key: 99149820
• Report Number: 0001825034-2018-00547
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK921301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

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: Physician
• Device Expiration Date: 07/31/2010
• Device Model Number: N/A
• Device Catalogue Number: 14-103560
• Device Lot Number: 909950
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 650-1058 CER BIOLOXD OPTION HD 40MM LOT 155450; EP-176235 E-POLY 40MM +5 MAXROM LNR LOT 367390
• Patient Outcome(s): Hospitalization; Required Intervention