MAUDE Adverse Event Report: ZIMMER BIOMET, INC. XLPE LINER STANDARD; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Ossification (1428); Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Osteolysis (2377); Reaction (2414)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: femoral stem fiber metal midcoat collarless 12/14 neck taper standard neck offset cementless size 12 standard body, pn 00784501200, ln 60428315, femoral head sterile product do not resterilize 12/14 taper, pn 00801803602, ln 61368537, shell porous with cluster holes 52 mm, pn 00620205222, ln 61079136 bone scr 6.5x25 self-tap, pn 00625006525, ln 61233964.Multiple mdr reports were filed for this event, please see associated reports 0001822565-2019-04580, 0002648920-2019-00770, 0001822565-2019-04578.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient had an initial left tha.Subsequently, the patient was revised approximately 9 years later due to pain, metallosis, limited mobility range of motion, tendinitis, swelling, tissue damage, heterotopic ossification, implant migration, implant fracture, pseudotumor/pseudocapsule, and osteolysis.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Reported event was confirmed by review of medical records noting liner fracture and dislodgment with some metallosis.Progressive worsening pain and difficulty walking.Mri noted moderate fluid posterior to the hip continuing around the lateral aspect of the greater trochanter.Aspiration of the hip joint showed dark blood negative on culture.Patient has severe pain with range of motion.Patient is experiencing shifting and has a popping sensation although no dislocation.Tissues were very poor quality and poor turgor.A lobulated mass of dark gray tissue was identified.A small amount of fluid in the joint space that was dark and slightly clotted with blood was removed.Cultures and heterotopic tissue were sent to the lab.Inside the capsule was multiple cartilage fragments.The locking mechanism of the shell was bend and flattened.The posterior superior aspect of the cup was somewhat flattened with a small notch in the neck below the trunnion.The stem was found to be well fixed.The gluteus medius and miniumus muscles were very thin but not eroded or damaged by the metallosis reaction.During removal of the cup, some posterior superior bone thinning was noted and a large amount of the anterior posterior column was preserved but there was somewhat of a deficiency posteriorly.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.

• Brand Name: XLPE LINER STANDARD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9243436
• MDR Text Key: 164102587
• Report Number: 0001822565-2019-04576
• Device Sequence Number: 1
• Product Code: KWA
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 00630505036
• Device Lot Number: 61333463
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2020
• 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