MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUSTOM SHELL; PROSTHETIC, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: unknown screw, unknown screw, unknown 12mmx150mm arcos stem, unknown size b x60mm high offset body, unknown standard length 28mm cocr head, unknown medium 40mm dm poly mobile liner.G2: foreign: united kingdom.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01669, 0001825034 - 2023 - 01668.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.

Event Description

It was reported that the patient has one screw holding the implant in place with two screws floating loose.The patient continues to experience pain, difficulty with activities of daily living and inability to ambulate.There is no additional information available at the time of this report.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on evaluation of medical records.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: custom acetabulum due to acetabular defect and metallosis damage.The implant has one screw holding it and has loosened 2 screws floating.Patient continues experiencing pain and difficulties with daily living.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: UNKNOWN CUSTOM SHELL
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17365951
• MDR Text Key: 319475067
• Report Number: 0001825034-2023-01667
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

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: Lay User/Patient
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female
• Patient Race: White