MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN MALLORY-HEAD CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - unknown femoral head, unknown hexloc liner, unknown ringloc liner, unknown bi-metric stem, all catalog#'s: ni, all lot#'s: ni.Event occurred in (b)(6).The following could not be completed with the limited information provided.Date of event - ni, expiration date - ni, date implanted - ni, date explanted - ni, manufacture date - ni.It has been indicated that the product will not be returned to zimmer biomet, as its location is unknown.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.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.Palomäki, a., lempainen, l., matilainen, m., eskelinen, a., remes, v., virolainen, p., mäkelä, k.T.(2017).Survival of uncemented cups from a single manufacturer implanted from 1985 to 2103: finnish arthroplasty register data.Archives of orthopaedic and trauma surgery, 137, 311-320.

Event Description

It was reported in a journal article that 12 patients underwent revision procedures due to implant fracture.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN MALLORY-HEAD CUP
• 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: 6427265
• MDR Text Key: 70638966
• Report Number: 0001825034-2017-01883
• Device Sequence Number: 1
• Product Code: KMC
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2017

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/23/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention