MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 48ODX42ID; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Bone Fracture(s) (1870); Osteolysis (2377); Reaction (2414); No Information (3190)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown-unknown m2a head-unknown.Unknown-unknown m2a stem-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01716.0001825034 - 2020 - 01718.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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.Product location unknown.

Event Description

It was reported that the patient is experiencing unknown issues.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported the patient underwent a revision surgery approximately 10 years post implantation due to metallosis, osteolysis, elevated metal ions and noise.During the procedure gray tissue was noted around proximal femur.Osteolysis noted at proximal femur with greater trochanter fragmentation and displacement, superior and proximal.Magnum cup, head, and taper adapter explanted without difficulty.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Cmp- (b)(4).D11: 157442 lot 970710 (m2a magnum modular hd, sz 42mm).139256 lot 094850 (m2a magnum taper adapter).11-103202 lot 745950 (taperloc modular lateralized femoral stem, sz 7.5mm).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed via medical records and radiographs reviewed by a health care professional.Review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event for item us157848 and 157442.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 additional information on reported event.

• Brand Name: M2A-MAGNUM PF CUP 48ODX42ID
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9985159
• MDR Text Key: 188468777
• Report Number: 0001825034-2020-01714
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: N/A
• Device Catalogue Number: US157848
• Device Lot Number: 746280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Hospitalization; Other; Required Intervention