MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A MOD HEAD; HIP PROSTHESIS

Model Number N/A

Device Problems Material Erosion (1214); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Discomfort (2330); Toxicity (2333)

Event Date 09/28/2015

Event Type  Injury  

Event Description

The legal counsel for patient reports patient underwent an initial total hip replacement arthroplasty on an unknown date.Subsequently, patient underwent a revision procedure on an unknown date in (b)(6) 2011 due to allegations of pain, discomfort, soreness, dysfunction, loss of range of motion, and metallosis.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.The following sections could not be completed with the limited information provided.Implant date: 2002; (b)(6) 2011.- explant date: (b)(6) 2011; (b)(6) 2015.

Event Description

The legal counsel for patient reports patient underwent an initial total hip replacement arthroplasty in 2002.Subsequently, patient underwent a revision procedure on an unknown date in (b)(6) 2011 due to allegations of pain, discomfort, soreness, dysfunction, loss of range of motion, and metallosis.A polyethylene acetabular liner was implanted during the revision.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received reported patient was revised (b)(6) 2015 due to instability from recurrent dislocation.The liner and head were removed and replaced.

Manufacturer Narrative

Therapy date - (b)(6) 2011 or (b)(6) 2015.Concomitant medical product - unknown acetabular cup, unknown femoral stem.It is unknown during which revision procedure the device was removed.(b)(4).This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-01484 / 1825034-2016-04954 ).

Manufacturer Narrative

Customer has indicated that the product will not be returned as the location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted if necessary.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

Reported event was unable to be confirmed due to limited information received from the customer.A head was returned and evaluated against the complaint.Visual inspection of the head shows it is scratched, scuffed, and damaged.A larger amount of scratching and scuffing was found on the bottom half of the head.There were dents and deformation surrounding the base of the head which likely occurred during the removal of the head.No corrosion or debris was observed within the taper of the head.Dimensional analysis was performed and found to be within specification.Dhr was reviewed and no related manufacturing deviations or anomalies were identified.Root cause was unable to 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.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Corrected.The date of initial implantation is unknown.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.

• Brand Name: 32MM M2A MOD HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 3669516
• MDR Text Key: 4343539
• Report Number: 0001825034-2014-01484
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/23/2018

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 Expiration Date: 07/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-163668
• Device Lot Number: 199680
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Initial Date Manufacturer Received: 02/10/2014
• Initial Date FDA Received: 03/10/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 07/31/2018; 09/12/2018
• Supplement Dates FDA Received: 12/08/2015; 11/30/2016; 03/21/2017; 08/28/2018; 09/14/2018
• 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