MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHETIC, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Reaction (2414)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer femoral head sterile product do not resterilize 12/14 taper, cat#00801803601, lot#62783553.Zimmer liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell, cat#00630505636, lot#62718394.Zimmer shell porous with cluster holes 56 mm o.D., cat#00620005622, lot#62401336.Zimmer bone scr 6.5x25 self-tap cat#00625006525, lot#62587130.Zimmer bone scr 6.5x30 self-tap cat#00625006530, lot#62429067.Zimmer femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 10 standard offset, cat#00771101000, lot#62688102.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, associated reports: 0002648920 - 2020 - 00392, 0002648920 - 2020 - 00391.

Event Description

It was reported the patient underwent a right hip arthroplasty.Subsequently, patient was revised approximately 6 years later due to elevated metal ion levels, metalosis, in-vivo corrosion, altr, pseudotumor and pain.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a revision procedure due to failed hip arthroplasty.Lab work revealed elevated metal ions - cobalt 9.3 h <=1.0 ug/l serum, and chromium 2.2 <=5.0 ug/l.Trunnionosis and alval were observed during the revision procedure.Copious synovial fluid consistent with metallosis was present in the joint.There was pseudotumor in the joint capsule.The femoral head and liner were replaced with new zimmer biomet products.No other complications/findings related to the event were noted.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

Event Description

No further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10612330
• MDR Text Key: 209338031
• Report Number: 0001822565-2020-03397
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00771101000
• Device Lot Number: 62688102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/18/2021
• 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
• Patient Weight: 77