MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-MAGNUM PF CUP 54ODX48ID; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Reaction (2414); Metal Related Pathology (4530)
Date of Event	02/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions." number 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-02595 / 02596).Additional event(s) for this patient reported on medwatch number(s) 1825034-2016-02587 / 02588 / 02590 / 02589.Device location unknown.
Event or Problem Description
Patient's legal counsel reported that the patient underwent a right hip revision approximately 8 years post-implantation due to metallosis and loosening.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Review of medical records reveals that the patient had loosening of the acetabular cup and tissue damage with fluid and thickening of the capsular lining.Review of invoice history revealed that the femoral head was removed and replaced.The acetabular cup was removed and replaced with a competitor acetabular cup and liner.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10: catalog number:157448 lot number:747430 brand name: m2a-magnum pf cup 54odx48id catalog number:us157854 lot number:759050 brand name: m2a-magnum pf cup one m2a-magnum mod hd sz 48mm and one m2a-magnum pf cup 54odx48id were returned and evaluated.Upon visual inspection cup has scuffing on the inner radius along with some debris on the od.The returned head has scuffing on the od and upon inspection of the taper there is no visible debris.Complaint sample was evaluated and the reported event was not confirmed.Review of device history records found these units were released to distribution with no deviations or anomalies.The additional information does not change the outcome of the previous investigation.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: M2A-MAGNUM PF CUP 54ODX48ID
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 5799421
• Report Number: 0001825034-2016-02588
• Device Sequence Number: 1242274
• Product Code: KWA
• UDI-Device Identifier: 00880304449510
• UDI-Public: (01)00880304449510(17)301116(10)759050
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K042037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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
• Operator of Device: Physician
• Device Expiration Date: 11/30/2016
• Device Model Number: N/A
• Device Catalogue Number: US157854
• Device Lot Number: 759050
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2016
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 07/15/2016
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female