MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Anemia (1706); Atrial Fibrillation (1729); Inflammation (1932); Memory Loss/Impairment (1958); Necrosis (1971); Pain (1994); Scar Tissue (2060); Synovitis (2094); Sleep Dysfunction (2517); Taste Disorder (4422); Unspecified Nervous System Problem (4426); Metal Related Pathology (4530); Decreased Appetite (4569); Swelling/ Edema (4577)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
( b)(4).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.Multiple reports were submitted along with this report : 0001822565-2021-02490.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.
Event or Problem 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.No further event information available at the time of this report.

• Brand Name: FEMORAL HEAD STERILE
• Common Device Name: 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: 12693171
• Report Number: 0002648920-2021-00376
• Device Sequence Number: 17156643
• Product Code: LPH
• UDI-Device Identifier: 00889024144675
• UDI-Public: (01)00889024144675(17)211130(10)61932015
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 61932015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention