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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Anemia (1706); Atrial Fibrillation (1729); Memory Loss/Impairment (1958); Sleep Dysfunction (2517); Taste Disorder (4422); Unspecified Nervous System Problem (4426); Metal Related Pathology (4530); Decreased Appetite (4569)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product: unknown head.Multiple reports were submitted along with this report 0001822565-2021-02491.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to elevated ion levels, joint infection and metallosis approximately 9 years post implantation.It was also noted that the patient suffered from loss of circadian rhythm, loss of deep sleep, complete loss of short-term memory, partial loss of long-term memory, loss of executive functions (organizing etc), hypersensitivity of taste (too sweet, too salty), loss of appetite.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

D10: catalog number: 00801803202 lot number:61932015 brand name: cocr heads.Catalog number:00625006525 lot number: 61948737 brand name: trilogy screw.Catalog number: 00620005422 lot number: 61832848 brand name: acetabular shell.Catalog number: 00630505032 lot number: 61859156 brand name: xlpw liner.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: x-rays taken leading up to the revision showed a stable joint with only heterotopic ossification and fine metal debris found, additional testing showed elevated metal ion levels.The patient also suffered from many symptoms from the high cobalt level.With increasing pain, during the revision.Corrosion was found at the neck and head junction, with some swelling in surrounding tissues.A new head and liner was placed and the wound was irrigated.Reported event was confirmed by review of medical records provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Root cause could not 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 STEM BEADED
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12436488
• MDR Text Key: 270252975
• Report Number: 0001822565-2021-02490
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00784301406
• Device Lot Number: 61803229
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention