MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Reaction (2414)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00784301136, femoral stem beaded fullcoat collared 12/14 neck taper standard neck offset size 11 lm body cementless, 62928926.00875201236, liner elevated rim 36 mm i.D.Size kk for use with 56 mm o.D.Size kk shell, 62819774.00875705602, shell with multi holes porous 56 mm o.D.Size kk for use with kk liners, 63048365.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00037.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right hip revision approximately 3 years and 10 months¿ post-implantation due to pain, pseudotumor, and elevated ion levels.Operative report notes there was a very large cavity of necrotic tissue consistent with pseudotumor that extended from the posterior joint and tracked along the vastus lateralis and up into the gluteus medius tendons.The lateral trochanter was completely bald and appeared necrotic.The edge of the gluteus medius tendon appeared to be necrotic and avascular.The short external rotators were involved with the metallosis as well, creating some avascularity of the tendons.There was black corrosion around the head ball as well as the trunnion consistent with metal on metal corrosion.Liner and head were revised.Patient has experienced severe pain, emotional distress, functional impairment of his right leg and permanent damage to tendons and abductor muscles.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6.Reported event was confirmed via medical records provided and reviewed by a healthcare professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11116636
• MDR Text Key: 229370145
• Report Number: 0002648920-2021-00003
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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: 00801803604
• Device Lot Number: 63172277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 81