MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Multiple mdrs were submitted for this event.Please see reports: 0002648920-2017-00784.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported the patient is being considered for a future revision to address reoccurring dislocation, initially treated with closed reduction.Noise and leg length discrepancy was also reported secondary to the multiple dislocation events.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information the corrections contained within this report have no effect on previous investigation conclusion.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.

Manufacturer Narrative

Reported event was confirmed through review of radiographs and medical records.Device history record was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.A summary of the investigation has been sent to the complainant.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: FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7154294
• MDR Text Key: 96036303
• Report Number: 0002648920-2017-00783
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2018

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: Physician
• Device Expiration Date: 01/09/2020
• Device Model Number: N/A
• Device Catalogue Number: 00801803601
• Device Lot Number: 61401740
• Other Device ID Number: DI#00889024144712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 01/30/2018; 02/01/2018
• Supplement Dates FDA Received: 01/30/2018; 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00630505636 LINER STANDARD. SHELL, LOT 61312837
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 75