MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E-POLY 32MM +3 MAXROM LNR SZ22; PROSTHESIS, HIP

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant product: unk, unknown cup, unk.Unk, unknown head, unk.Unk, unknown stem, unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 06589.

Event Description

It was reported that a patient underwent an initial hip procedure.Subsequently, the patient has been experiencing instability with the implant.The surgeon has planned to have another surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the intial medwatch.(b)(4).Medical devices: 650-1056, cer bioloxd option hd 32mm, 313600; 51-103130, tprlc 133 type1 pps so 13.0, 3795925; pt-116050, regen/rnglc+ ltd 50mm sz 22, 865550.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 06589 - 1.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: E-POLY 32MM +3 MAXROM LNR SZ22
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6848307
• MDR Text Key: 85126317
• Report Number: 0001825034-2017-06588
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/06/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-108222
• Device Lot Number: 401200
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• 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
• Patient Outcome(s): Other