MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM PRESS-FIT COLLARLESS 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Cancer (3262)
Date of Event	08/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number: 00875706001, lot number: 64049358 brand name: acetabular shell, catalog number: 00885101440, lot number: 63831459 brand name: acetabular liner , catalog number: 00786401400, lot number: 63985581 brand name: femoral stem, catalog number:00877504001, lot number: 2935332 brand name: femoral head, catalog number:00625006530, lot number: 64047518 brand name: bone screw.Multiple reports were submitted along with this report 0002648920-2022-00138.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.A month later, the patient was still experiencing pain and stiffness, but is not an unexpected finding.The patient was suffering from severe pain and inability to bear weight.A revision occurred for loosening of the stem implant, however a broken screw was not identified within the op notes or diagnosis.X-rays taken the same day as the revision showed a possible broken screw component, but it could not be confirmed.The stem and head were explanted and zimmer products were placed.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 pain and loosening approximately two (2) years post implantation.On an x-ray completed prior to the revision, it appeared that there was a broken screw component projected over the lateral cortex but is unable to be confirmed based upon operative note, operative diagnosis, explanted product, or additional imaging.During the revision, the stem and the head were revised and all other components remained in place.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified: the patient was complaining of pain at an office visit, and an x-ray showed a subtle stress fracture around the shaft of the stem with callus formation.An mri 2 days later showed a muscle strain.The bone fracture was not confirmed in the revision notes.Root cause unchanged.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 a right total hip revision was performed approximately 2 years post implantation due to pain and loosening.Additionally, a periprosthetic distal end femoral stress fracture was noted on x-ray (but not confirmed in revision notes).On an x-ray, completed after the revision, it appeared that there was a broken screw component projected over the lateral cortex but is unable to be confirmed based upon operative note, operative diagnosis, explanted product, or additional imaging.During the revision, the stem and the head were revised with zb products and all other components remained in place.No additional information.

• Brand Name: FEMORAL STEM PRESS-FIT COLLARLESS 12/14
• 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: 15095422
• Report Number: 0001822565-2022-02211
• Device Sequence Number: 14783194
• Product Code: LPH
• UDI-Device Identifier: 00889024151499
• UDI-Public: (01)00889024151499(17)310528(10)64049358
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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 Model Number: N/A
• Device Catalogue Number: 00786401400
• Device Lot Number: 63985581
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White