MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM PF CUP 60MM X 54MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Erosion (1750); Cyst(s) (1800); Pain (1994); Synovitis (2094); Tissue Damage (2104); Blood Loss (2597); No Code Available (3191)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see reports: 0001825034-2017-07603.Concomitant medical products: 11-104112 mlry-hd por fmrl 12 x 165 mm lot# 061370, us157860 60od x 54 id magnum pf cup lot# 704310, 139266 m2a-magnum 52-60 mm tpr insrt-3 lot# 744220, 157454 m2a-magnum mod hd sz 54 mm 54 mm lot# 226620.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient underwent hip revision to address a painful metal on metal total hip replacement with synovitis and cystic lesion right hip.During the procedure, partial attritional erosion of gluteus medius insertional attachment was noted.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and visual evaluation of sample.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A m2a-magnum pf cup 60odx54id, part # us157860 from lot 704310, was returned and evaluated against the complaint.Visual inspection found scratching on the inner radius consistent with metal on metal construction.Foreign debris and discoloration were observed on the outer radius of the cup.Additional information provided does not change the root cause of the previous investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.The patient presents with increasing pain and squeaking of the right hip, the patient also experienced elevated metal ion levels.All components were found to be secure.The acetabular component was excessively anteverted and in a vertical position.There was evidence of modest trunnion corrosion by gross inspection.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 patient underwent revision surgery approximately 10 years post initial surgery due to due to pain, squeaking of the hip, and elevated metal ions.During the revision, the acetabular shell was noted to be excessively anteverted and in a vertical position.Synovitis, cystic lesion, and trunnion corrosion were also noted.The femoral head and cup were replaced.There was an estimated blood loss of 800 ml.

• Brand Name: M2A MAGNUM PF CUP 60MM X 54MM
• 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: 6911102
• MDR Text Key: 88038477
• Report Number: 0001825034-2017-07685
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: US157860
• Device Lot Number: 704310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention