MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS HIP

Device Problems Material Erosion (1214); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for 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.Concomitant products: part # unknown / unknown head/ lot # unknown.Part # unknown / unknown shell/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -01014.0001825034 -2021 -01015.

Event Description

It was reported that patient was revised 13 years post implantation due to metal related pathology and extensive altr.Medical records stated, abductor muscles were partially torn from the gt, hypertrophic trochanteric bursal tissue with fibrillated abductor muscle tendon edges, consistent with attrition of the tendons and a chronic tear of the abductor muscle, metallic wear debris with resultant osteolysis and weakened bone attachments.The right femoral implant was loose, no solid bony ingrowth onto the roughened surface of the proximal stem.Acetabular component was completely fixed.Areas of burnishing from mom contact and wear.The right acetabular implant was well fixed but was burnished and scratched and would not accept a dual mobility poly without resulting in excessive and accelerated wear.All components were replaced with competitor product without complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) findings: preop dx: severe proximal right femoral osteolysis and bone deficiency, loose femoral stem, acetabular component surface damage, mom wear, altr pseudotumor, destruction and detachment of abductor muscles, femoral cortical defect and stress fracture due to osteolysispatient presented with groin pain, recent metal ion levels cobalt 2.1 (normal <4.0), chromium 2.1 (normal <0.6).Pain increased despite injections, rom limited by pain.Sensations of mechanical clunking, cracking, and shifting have been noticed.Labs negative for infection.Abductor muscles were partially torn from the gt, hypertrophic trochanteric bursal tissue with fibrillated abductor muscle tendon edges, consistent with attrition of the tendons and a chronic tear of the abductor muscle metallic wear debris with resultant osteolysis and weakened bone attachments.The right femoral implant was loose.No solid bony ingrowth onto the roughened surface of the proximal stem.Acetabular component was completely fixed areas of burnishing from mom contact and wear.In addition to the above, scar tissue and heterotopic bone debrided from the joint.The right acetabular implant was well fixed but was burnished and scratched and would not accept a dual mobility poly without resulting in excessive and accelerated wear.Some areas around the cup had been affected by metallic osteolysis but fixation was not compromised.Spot welds palpated in multiple quadrants circumferentially.All components revised, competitor product placed root cause could not 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.

Event Description

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

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11655329
• MDR Text Key: 245090315
• Report Number: 0001825034-2021-01016
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 104