MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL BODY NITRIDED 12/14 NECK TAPER 40MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog#: 00998201613 femoral stem taper nitrided 16 mm d 35mm stem l lot#: ni, catalog#: 00630505636 liner standard 3.5 mm offset 36 mm i.D.Lot#: 63011059, catalog#: 00801803603 femoral head 12/14 taper lot#: ni, catalog#: 00998604025 trephine 16.5mm id x 8in lot#: ni, catalog#: 11-301017 arcos 17x250mm spl tpr dist lot#: 938120, ,catalog#: 00630505636 liner standard 3.5 mm offset 36 mm i.D.Lot#: 63687030n, catalog#: 650-0662 delta ceramic fem hd 36/+3mm lot#: 3053017, catalog#: 11-301310 arcos con sz a hi 50mm lot#: 135070, catalog#: 00998604028 trephine 18mm id x 8in lot#: ni, catalog#: 00998604030 trephine 19.5mm id x 8in lot#: ni ,catalog#: 00998604029 trephine 18.5mm id x 8in lot#: ni.The device will not be returned for analysis, as the patient has not returned; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-02359.
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately 4 years and 7 months after initial implantation due to a broken hip implant.The implants were extracted after performing an eto using trephines and manual extraction devices.The femoral canal was prepared for a 250mm arcos stem and 50mm high offset cone body & liner was exchanged.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed by review of radiographs.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.Visual examination of the provided pictures identified the stem/femoral body had fractured in half.Products are covered in bio-debris.No further evaluation can be made from the provided pictures.Radiographs identified a gap between the femoral body and the femur, but nothing denoting a lack of proximal support in the report.No evidence of osteolysis.The stem is in good position in the canal, and there is good distal fixation.It was noted that the size of the proximal body was inadequate (small) relative to the femur, but the shape is adequate.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Root cause unchanged.This complaint was confirmed based on the provided pictures.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
His follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem Description
It was reported that a patient underwent an initial left total hip arthroplasty.The patient was revised one year post implantation.The head and stem were revised due to loosening of the femoral component with failure to osteointegrate.The patient did well until he was getting out of his truck and felt a pop with intense pain.The patient went to the emergency department where a fracture of the femoral stem was identified on x-ray.The patient was revised for a second time, five years later, to remove the fractured stem.An extended trochanteric osteotomy was performed but was not stable.Cerlcage cables and a femoral strut graft was placed to stabilize the femur after stem, head, and liner exchange.The initial shell remained well-fixed and was left in place.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h6.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.A revision occurred on due to loosening of the femoral component with no osseointegration.Since then, he has been noted to have degenerative changes in his bones in multiple areas of his body, with a fall noted as well.The patient felt a sharp pain when getting out of his truck.X-rays determined the stem had fractured.A revision occurred during which the femur fractured while removing the stem.The head, liner, and stem construct were explanted and replaced with zb products.The previous radiograph review indicates there was a gap between the proximal body and the femur.As x-rays were not provided prior to the fracture, it cannot be confirmed if the proximal body was properly supported initially, or degenerative changes may have caused the gap that was noted.A definitive root cause cannot be determined.With the information provided it cannot be determined if the proximal body was supported initially or degenerative changes/a fall caused the gap noted between the body and the femur.This complaint was confirmed based on the provided pictures of the fractured device, medical records, and x-rays.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: FEMORAL BODY NITRIDED 12/14 NECK TAPER 40MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12358068
• Report Number: 0001822565-2021-02349
• Device Sequence Number: 17112139
• Product Code: LPH
• UDI-Device Identifier: 00889024162365
• UDI-Public: (01)00889024162365(17)260131(10)63243724
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K113296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/02/2024

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00999601745
• Device Lot Number: 63243724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 09/29/2023; 01/25/2024; 02/06/2024; 04/01/2024
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 11/01/2021; 10/16/2023; 01/26/2024; 03/01/2024; 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2016
• 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: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Race: White