MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Migration or Expulsion of Device (1395); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Blood Loss (2597)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0002648920 - 2018 - 00569.Additional concomitant medical products: 00801803602 femoral head, lot 62245638; 00630506236 liner, lot 62265659; 00620006222 shell, lot 62268632.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported patient underwent a revision procedure approximately four years post-implantation due stem loosening and alval corrosion reaction.Pre-revision radiographs identified lucencies which indicated possible early loosening of the left femoral stem with mild resorption and early osteolysis.Intraoperatively, it became "immediately evident [that] there was a pseudotumor in the posterior aspect of the soft tissues" and that when it was opened "copious fluid came out of the hip." the surgeon also noted that there was extremely thick scar tissue, "large handfuls of necrotic debris excised from the pseudotumor" and "obvious corrosion" that occurred between the femoral head/neck interface.The surgical pathology removed during the procedure was evaluated and found to be histologically consistent with aseptic, lymphocytedominated vasculitis associated lesion (alval) reaction (trunnionosis due to head/ neck taper junction corrosion).No further information has been made available at this time.

Manufacturer Narrative

(b)(4) no device was returned for review.Radiograph review confirms the report.Review of device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.Root cause is undetermined.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 information has been made available at the time of this reporting.

Manufacturer Narrative

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

It was reported patient underwent a revision procedure approximately four years post-implantation due stem loosening and alval corrosion reaction.Pre-revision radiographs identified lucencies which indicated possible early loosening of the left femoral stem with mild resorption and early osteolysis.Intraoperatively, it became immediately evident [that] there was a pseudotumor in the posterior aspect of the soft tissues and that when it was opened copious fluid came out of the hip.The surgeon also noted that there was extremely thick scar tissue, large handfuls of necrotic debris excised from the pseudotumor and obvious corrosion that occurred between the femoral head/neck interface.The surgical pathology removed during the procedure was evaluated and found to be histologically consistent with aseptic, lymphocytedominated vasculitis associated lesion (alval) reaction (trunnionosis due to head/ neck taper junction corrosion).The patient had a estimated blood loss of 1500 ml during revision surgery.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of radiographs and medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records were provided and reviewed.Records indicate patient was revised due to pain and was diagnosed with radiolucencies suggestive of osteolysis and loosening of the femoral stem.Aseptic loosening left femoral stem and alval corrosion reaction left hip.Pseudotumor with copious fluid identified and excised.Necrotic tissue noted without acute inflammation.Extremely thick scar tissue identified.Abductor tendons had some dysfunction and were slightly stripped off the far posterior corner of the trochanter.Obvious corrosion noted between femoral head and neck.There was a blood loss of 1500ml.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: FEMORAL STEM 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7767429
• MDR Text Key: 116557562
• Report Number: 0001822565-2018-03833
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00771101000
• Device Lot Number: 62101422
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2019
• 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