MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CER BIOLOXD OPTION HD 40MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Test Result (2695); Fibrosis (3167)

Event Date 06/10/2014

Event Type  Injury  

Event Description

Patient's legal counsel reported patient underwent bilateral total hip arthroplasty on (b)(6) 2009.Legal counsel further reports patient underwent left revision procedure on (b)(6) 2014 due to patient allegations of pain and elevated metal ion levels.The cup and head were removed and replaced.No revision procedure has been reported for the right hip to date.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Additional information received in the patient's revision operative report noted the reason for left hip revision on (b)(6) 2014 was pain.Operative report further noted metal tinged fluid and thick fibrous reactive tissue along iliopsoas tendon.Additional information received in the patient's revision operative report noted patient underwent a left hip revision on (b)(6) 2014 due to dislocation.A closed reduction was attempted, but was unsuccessful necessitating an open reduction.The acetabular liner and modular head were replaced with a constrained liner and head.

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: "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity.Muscle and fibrous tissue laxity can also contribute to these conditions." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 6 of 6 mdrs filed for the same event (reference 1825034-2014-09126/ -09129 & 1825034-2015-02116 & 1825034-2015-02118).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: m2a-magnum pf cup 54odx48id, cat: us157854, lot: 921280; m2a-magnum mod hd sz 48mm, cat: 157448, lot: 231900; m2a-magnum mod hd sz 48mm, cat: 157448, lot: 843610; m2a-magnum pf cup 54odx48id, cat: us157854, lot: 298150; e-poly 40mm 10deg lnr sz25, cat: ep-109925, lot: 666750.Reported event was confirmed by review of medical records.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.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

Multiple reports have been submitted for the event.Please see associated reports: 0001825034-2014-09127, 0001825034-2015-02116, 0001825034-2015-02118, 0001825034-2014-09126, 0001825034-2014-09129, 0001825034-2014-09128.

Event Description

The patient underwent a second left revision surgery approximately 2 months later due to a second dislocation.Attempts have been made, and no further information has been provided.

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.

• Brand Name: CER BIOLOXD OPTION HD 40MM
• 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: 4781995
• MDR Text Key: 5852881
• Report Number: 0001825034-2015-02118
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,distributor,health profess
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 650-1058
• Device Lot Number: 708650
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• 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: 49 YR