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

Model Number N/A

Device Problems Flaked (1246); Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00151603036, impactor for use with 36 mm i.D.Cup, 62989799, 00151603040, impactor for use with 40 mm i.D.Cup, 63148868, 00151603044, impactor for use with 44 mm i.D.Cup, 63148869.Report source, foreign ¿ events occurred in (b)(6).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.

Event Description

It was reported that the maxera coating particles were found impacted on the white impactor surface possibly causing serious injury to patient.Information regarding patient involvement has not been reported to date.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.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.

Event Description

It was reported that the maxera coating particles were found impacted on the white impactor surface possibly causing serious injury to patient.Information regarding patient involvement has not been reported to date.

• Brand Name: UNKNOWN MAXERA CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7205098
• MDR Text Key: 97716089
• Report Number: 0001825034-2018-00350
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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 Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other