MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KINECTIV MODULAR FEMORAL STEM PRESS-FIT CEMENTLESS SIZE 13.5; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Radiolucent Lines (4848)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 1 year later due to instability, subsidence, aseptic loosening, pain, and recurrent dislocations.During the revision no bone growth was noted on the femoral component.All components were revised.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877503202 lot# 3114771 biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14 cat# 00620205222 lot# 65712802 shell porous with cluster holes 52 mm.Cat# 00625006530 lot# j7422663 bone screw self-tapping 6.5 mm dia.30 mm length.Cat# 00625006530 lot# 65721828 bone screw self-tapping 6.5 mm dia.30 mm length.Cat# 00784802200 lot# 65587381 modular neck b 12/14 neck taper use with +0 heads only.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
Proposed component code: mechanical (g04)-stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records and timeline identified the following: during a clinical visit prior revision the following was noted: left hip pain for 1 year, reports hip keeps popping out of place.5 dislocations since hip replacement.Failure of ingrowth left femoral stem with subsidence, no fracture, pedestal and peripheral radiolucency femoral component.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: KINECTIV MODULAR FEMORAL STEM PRESS-FIT CEMENTLESS SIZE 13.5
• 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: 19655691
• Report Number: 0001822565-2024-02213
• Device Sequence Number: 6596532
• Product Code: LPH
• UDI-Device Identifier: 00889024132665
• UDI-Public: (01)00889024132665(17)320617(10)65353372
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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 Model Number: N/A
• Device Catalogue Number: 00771301300
• Device Lot Number: 65353372
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 66 KG