MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Unequal Limb Length (4534)

Event Date 08/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 00801803602 ¿ cocr head ¿ 61132297.00630505036 ¿ xlpe liner ¿ 61221990.00625006525 ¿ bone screw ¿ 61207574.00625006530 ¿ bone screw ¿ 61070821.00620005022 ¿ shell ¿ 60982739.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2021 - 00128.

Event Description

It was reported that patient underwent a right hip revision approximately 8 years post implantation due to pain and elevated metal ion levels.During the revision, corrosion was noted at the head-taper junction.The head was removed and replaced without complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: g3; h2; h3; h6.Corrected: d4(catalog number).Medical records were reviewed by a health care professional and note patient experiencing a painful right hip, trunnionosis with armd, limb length discrepancy.Workup indicated elevated serum cobalt, no evidence of infection.Femoral head showed blackening consistent with corrosion at the trunnion.Stem and shell well fixed, liner did show some possible evidence of mild oxidation.Thick scarring at the bursal tissue, cloudy yellow fluid was encountered.Dhr was reviewed and no discrepancies were found.The root cause is 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 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.

Event Description

No additional information on the reported event.

• Brand Name: M/L TAPER STEM
• 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: 12017630
• MDR Text Key: 256746790
• Report Number: 0001822565-2021-01678
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 00771100920
• Device Lot Number: 61112027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2008
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 63 KG