MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 62ODX56ID; PROSTHESIS, HIP

Model Number N/A

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item number: unknown, item name: unknown head, lot #: unknown, item number: unknown, item name: unknown liner, lot #: unknown, item number: unknown, item name: unknown stem, lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent hip revision on an unknown date.Subsequently, patient has been indicated for revision on an unknown date.Attempts have been made and no additional information is available.

Event Description

It was reported the patient had a right side resurfacing revision to address acetabular loosening.No further information is available at this time.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.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

No further information is available at this time.

• Brand Name: M2A-MAGNUM PF CUP 62ODX56ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7595665
• MDR Text Key: 110863126
• Report Number: 0001825034-2018-03936
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2019

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
• Device Catalogue Number: US157862
• Device Lot Number: 304180
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 02/04/2019; 04/05/2019
• Supplement Dates FDA Received: 02/06/2019; 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: US157356 LOT 700980 RECAP PF HA FMRL HD RESUR 56MM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR