MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown shell ¿ unknown part and lot.Unknown head ¿ unknown part and lot.Unknown liner ¿ unknown part and lot.Therapy date: unknown.Reported event was unable to be confirmed due to limited information received from the customer.Review of x-rays provided shows patient has dislocation of the right hip along with malpositioning, lucency of the acetabular component and extensive heterotopic ossification which appears to bridge the joint space with possible bony fusion.Device history record (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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05035, 0001822565-2018-05036, 0001822565-2018-05037.

Event Description

It was reported that patient is being considered for revision at a unknown amount of time post implantation for unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• 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: 7970003
• MDR Text Key: 123863977
• Report Number: 0001825034-2018-09730
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2018

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: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 10/16/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization