MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ML TAPER SZ12.5 STD OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

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

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: item# unknown; unknown head; lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 04292.

Event Description

It was reported patient underwent right total hip arthroplasty.Subsequently, patient underwent a revision procedure 8 years post implantation due to altr reaction secondary to tribocorrosion/pain.Attempts were made to obtain further information; however, none is available.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.Updated 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

Concomitant medical products: item number: 00-8018-040-02, item name: versys femoral head, lot #: 60829331, item number: unknown, item name: unknown longevity acetabular liner, lot #: unknown, item number: unknown, item name: unknown trilogy aceteabular shell, lot #: unknown.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported patient was revised approximately 11 years post implantation due to elevated metal ions and pain.During the procedure, a pseudotumor and altr due to taper corrosion was noted.The femoral head and acetabular liner components were removed and replaced.No additional information is available at this time.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: item# 00801804002 femoral head sterile product do not resterilize 12/14 taper lot# 60829331.Item# 00630506240 liner standard 3.5 mm offset 40 mm i.D.For use with 62 mm o.D.Shell lot# 60631968.Unknown cup.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.The event was confirmed with medical records received.Review of the provided medical records identified the following: patient underwent initial right tha on (b)(6) 2007 and no complications were noted.The patient was revised on (b)(6) 2018.Pseudotumor noted upon entry and dark stained tissue lining the joint.Corrosion buildup noted at the base of the femoral head and neck, tissue buildup in the groove of the locking ring and elevated cobalt levels.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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: ML TAPER SZ12.5 STD OFFSET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7806893
• MDR Text Key: 117921927
• Report Number: 0001822565-2018-04293
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-7711-012-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• 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 Age: 71 YR
• Patient Weight: 98