MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Noise, Audible (3273)

Patient Problems Pain (1994); Osteolysis (2377); Reaction (2414); Osteopenia/ Osteoporosis (2651)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01901.

Event Description

It was reported the patient underwent an initial left total hip arthroplasty 13 years ago.Subsequently, the patient was revised 2 years ago due to pain, noise, and elevated serum metal ion levels.During the revision, metallosis was present within the capsule.The acetabular shell was noted to be vertically positioned with osteolysis present behind the component.The head and shell were replaced without complication.The stem remained well-fixed and stable.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; h2; h3; h4; h6.Reported event was confirmed with medical records provided.Review of the available records identified the following: patient was revised to due metallosis, malposition acetabular component, osteolysis.Patient presented with worsening pain, mechanical catch, and audible clunk in the hip.Upon entry, immediate return of oxidized serous fluid consistent with metallosis encountered.Metallosis and fluid contained within the capsule, no loss of musculature or soft tissue damage.Trunnion normal with no damage, stem well fixed.The acetabular component was fixed and medialized at about 70 degree abducted angle.Cup removed without complication, osteolysis of the acetabulum present, 4x4cm defect noted in the centrally in the medial wall from osteolysis, bone chips used to repair the defect.Stem remained intact, all other components replaced without complication review of the device history records identified deviations or anomalies during manufacturing, however, the deviations or anomalies would not have attributed to the event.A definitive root cause cannot be determined.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 event information available at the time of this report.

• Brand Name: M2A-MAGNUM MOD HD SZ 50MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10067188
• MDR Text Key: 193627320
• Report Number: 0001825034-2020-01902
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 157450
• Device Lot Number: 063040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET CUP CAT#US157856 LOT#107300.; BIOMET STEM CAT#11-103206 LOT#147680.; BIOMET TAPER ADAPTER CAT#139256 LOT#849240.
• Patient Outcome(s): Hospitalization; Required Intervention