MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A HI CARBON HD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Toxicity (2333); Joint Dislocation (2374); Reaction (2414); Test Result (2695); Metal Related Pathology (4530)

Event Date 12/03/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent a left total hip arthroplasty on (b)(6) 2005.Patient's legal counsel reports patient allegations of pain, instability, dislocation and elevated metal ion levels.Subsequently, the patient was revised on (b)(6) 2012.The modular head was removed and replaced.Additionally, the patient was revised (b)(6) 2013.The modular head was removed and replaced.Review of invoice history indicates the patient had a femur fracture which was repaired during the (b)(6) 2012 revision procedure.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

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 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ 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 patient¿s complaint, and the allegations contained therein are unverified.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2014-00401/00403).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 2 of 4 mdr's filed for the same event (reference 1825034-2014-00401 / -00403 and -03957).

Event Description

Legal counsel for patient reported that patient underwent left total hip arthroplasty on (b)(6) 2005.Patient's legal counsel reports patient allegations of pain, instability, dislocation and elevated metal ion levels.Subsequently, the patient was revised on (b)(6) 2012.Additionally, the patient was revised (b)(6) 2013.Review of invoice history indicates the trochanter was repaired during the (b)(6) 2012 revision procedure.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Additional information received from patient's operative (op) notes dated (b)(6) 2012 reports patient was revised due to hip fracture.During the revision procedure, the op report notes scar tissue, black deposits in the soft tissue consistent with metallosis, cavitary defect, and heterotrophic bone were observed.The modular head was removed and replaced.Additional op notes dated (b)(6) 2013 reports patient was revised due to metallosis and for the removal of abductor mechanism.Op notes report the presence of bloody and dark-tinged fluid consistent with metallosis and a defect in the mid region of the hip abductors.The head was removed and replaced; the cup was removed and replaced with a competitor acetabular product.The stem remains implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via operative report.Operative report states patient was revised due to metallosis and for the removal of abductor mechanism.Op notes report the presence of bloody and dark-tinged fluid consistent with metallosis and a defect in the mid region of the hip abductors.The head was removed and replaced.The cup was removed and replaced with a competitor acetabular product.The stem remains implanted.One 32mm m2a hi carbon hd std nk item#: 11-163688, lot#: 618020 was returned and evaluated.Upon visual inspection there is some scuffing on the od of the device with no other visible damage.No other devices were returned.Device history record (dhr) was reviewed and no discrepancies were found.Additional information does not change the root cause of previous investigation.A definitive root cause cannot be identified.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 the reported event.

• Brand Name: 32MM M2A HI CARBON HD STD NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3574592
• MDR Text Key: 4076048
• Report Number: 0001825034-2014-00402
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-163688
• Device Lot Number: 618020
• 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
• Date Manufacturer Received: 12/31/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male