MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM TRABECULAR METAL SHELL WITH HOLES

Model Number N/A

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

Patient Problems Foreign Body Reaction (1868); Joint Dislocation (2374)

Event Date 05/21/2015

Event Type  Injury  

Event Description

It is reported the patient was revised to address dislocation and metallosis.

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.This report will be amended when our investigation is complete.

Manufacturer Narrative

The shell was not returned for further evaluation as it was discarded.Review of the image provided confirmed the presence of bone growth on the continuum shell.The image of excised tissue verified the adverse tissue reaction.The additional information provided did not alter the previous investigation conclusion.

Manufacturer Narrative

No devices or photos were received; therefore the condition of the continuum cluster shell, femoral stem is unknown.Review of the device history records for the lot code associated with the continuum shell and femoral stem identified no deviations or anomalies with the manufacturing process.The devices were used in an approved and compatible combination.These devices are used for treatment.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Adherence to rehabilitation protocol and relevant medical history are unknown.A probable cause for the metallosis noted is metal debris, most likely from the metal on metal construct.Please reference medwatch #9613350-2015-00673 for more information.It is unknown if the reported metallosis caused or contributed to the reported dislocation.With the information provided, a specific cause could not be determined for the reported condition.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This follow up report is being filed to relay additional information.Concomitant products: part 00625006535 name- self tapping bone screw lot- 61755421.

Event Description

Upon receipt of medical records patient experienced dislocation.Two attempts at closed reduction were unsuccessful resulting in revision of hip arthroplasty approximately 4 years post initial implantation.No other significant findings were noted on the pre operative x-ray; however there was noted near complete loss of his greater trochanter.Greyish type tissue was found during surgery and was excised.A previous greater trochanter repair was not functional.Metallosis was noted in the entirety of the soft tissues.Due to the extensive metallosis the cup was removed as well as the head liner and screw.Excellent ingrowth of the acetabular shell and no evidence of loosening.The stem was very well ingrown and did not need to be removed.No complications were noted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of provided op notes.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Review of the revision op notes reveal patient underwent a left hip revision procedure approximately four (4) years post implantation on due to dislocation and metallosis.Revision operative findings show surgeon noted some grayish type of tissues and extensive amount of bloody appearing fluid.Surgeon also noted previous greater trochanter repair was not functional.A definitive root cause for the reported event could not be determined with information available.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: CONTINUUM TRABECULAR METAL SHELL WITH HOLES
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4864865
• MDR Text Key: 5849235
• Report Number: 1822565-2015-00977
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00875705201
• Device Lot Number: 61768937
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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): Required Intervention
• Patient Age: 63 YR