MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 12.5 STAN; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	01/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign: country: canada.(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 02757.
Event or Problem Description
It was reported that the patient underwent a right hip revision procedure approximately 4 years post-implantation.The patient has experienced pain and discomfort in relation to the implantation of the product.Prior to the revision surgery, the patient underwent diagnostic testing of her blood chemistry; analysis conducted indicated that the patient had sustained high levels of chromium and cobalt concentrate.As a result, the patient has sustained and will sustain serious injuries to their body, the particulars of which include, but are not limited to the following: metallosis, tissue dehiscence, tissue necrosis, bone necrosis, hypertrophic scarring, antalgia, lumbar strain, chronic pain and severe emotional and/or psychological distress relating to the pain and suffering associated with the defective product.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2023-00030.Proposed component code: mechanical (g04)- stem.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed with no complications noted.A revision occurred approximately four(4) years later due to elevated metal ions, pain, and swelling.While in the joint, a pseudotumor was noted as well as black residue consistent with trunnionosis on the trunnion of the stem and inside the femoral head.The liner and head were removed and replaced with zimmer products with no complication noted.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
Initial right hip arthroplasty that was subsequently revised approximately four (4) years later due to metal-on-metal right total hip.During the revision metal on poly articulation was noted as well as periarticular pseudotumor and black debris.The femoral head and acetabular liner were explanted all other components remained.No intraoperative complications reported.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} proposed component code: mechanical (g04)- stem.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient's bmi was increased since the previous surgery.The elevated ion levels were also provided.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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 12.5 STAN
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15485536
• Report Number: 0001822565-2022-02758
• Device Sequence Number: 19671092
• Product Code: JDI
• UDI-Device Identifier: 00889024131866
• UDI-Public: (01)00889024131866(17)211231(10)61945467
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/03/2024
• 2 Devices were Involved in the Event: 1 2

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00771101200
• Device Lot Number: 61945467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 02/03/2023; 02/29/2024; 07/02/2024
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 03/01/2023; 03/21/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK CUP.; UNK HEAD.; UNK LINER.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 122 KG