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

Model Number N/A

Device Problems Unstable (1667); Migration (4003)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Patient Problem/Medical Problem (2688)

Event Date 09/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer biolox delta fem head, 32mm, +0mm - cat#00-8775-032-02, lot 3016058.¿ zimmer kinectiv modular neck g - cat#00-7848-023-00, lot 64640959.¿ zimmer m/l taper kinectiv stem size 9 - cat#00-7713-009-00, lot 64496426.¿ zimmer acetabular shell cat#00-6202-54-22, lot 64553177.¿ zimmer bone screw cat#00-6250-65-25, lot j6781969.¿ zimmer bone screw cat#00-6250-65-30, lot j6772013.¿ zimmer trilogy liner cat#00-6305-50-32, lot 64610351.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.

Event Description

It was reported that the patient underwent an initial right hip arthroplasty.Subsequently, the patient underwent a revision approximately 2 months later due to pain, peri-prosthetic fracture, instability, limited mobility, and stem subsidence.It was noted the patient sustained a fall; unable to bear weight and pain in his right hip.The head, neck and stem were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Operative notes were provided and reviewed by a healthcare professional.Review of the medical records identified the following: patient was revised due to pain, peri-prosthetic fracture, instability, limited mobility, and stem subsidence.The patient sustained a fall resulting in pain and being unable to bear weight.Cup was well fixed.Femoral component was noted to be subsided and easily removed.There was a large posteromedial spike on the femur.Hematoma was evacuated.Head, neck and stem were replaced.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.It was reported that the patient experienced a fall which could have contributed to the reported event however, a definitive 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 Description

No further event information available at the time of this report.

• Brand Name: MODULAR FEMORAL STEM PRESS-FIT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10665913
• MDR Text Key: 211054608
• Report Number: 0001822565-2020-03447
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K182678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00771300900
• Device Lot Number: 64496426
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 107