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)

Patient Problems Pain (1994); Local Reaction (2035); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part: 00771101500, lot: 60819299; part: 00620005622, lot: 60947319; part: 00630505632, lot: 60918150.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00491, 0002648920-2021-00034.

Event Description

It was reported patient underwent a revision procedure 13 years post-implantation due to corrosion at the head & neck interface.Pre-revision office visit reports corrosion and local metallosis.Mri report shows adverse local tissue reaction (altr), torn gluteus medius tendon, osteolysis anterior acetabular rim, moderate illopsoas bursitis containing wear induced debris, and microtear of hip adductor tendon.Head and liner exchanged.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a healthcare professional.Patient's history consists of right oa, lumbar scoliosis & stenosis, anemia, dm type ii, bilateral knee replacement 2010, 2019 laminectomy.Patient underwent an initial rtha on (b)(6) 2008, no intraoperative complications were identified.Office visit notes on (b)(6) 2021 identified patient experiencing pain.Mri was taken (b)(6) 2021 and noted altr, torn gluteus medius tendon, osteolysis anterior acetabular rim, rupture of large portion of gluteus medius tendon; moderate iliopsoas bursitis containing wear induced debris, microtear of hip adductor tendon, corrosion and local metallosis.Cobalt levels were elevated, at 7.1h.Patient underwent revision on (b)(6) 2021 due to corrosion at the head/neck junction; operative notes were not provided.Xrays were provided however were not reviewed as mri report is provided in the medical records, and provides full description of mri results, and plain x-ray submission would not enhance the investigation process.Review of the device history records for the stem and head identified no deviations or anomalies during manufacturing.Review of the device history records for the shell 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.

Event Description

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

• 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: 11378734
• MDR Text Key: 233498986
• Report Number: 0002648920-2021-00031
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

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
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 60988023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 96