MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer liner standard, cat#: 00630505832, lot#: 62042907.Unknown cup.Unknown stem.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital policies.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00282.

Event Description

It was reported that a patient underwent a tha 8 years ago.Subsequently, the patient underwent a revision due to patient rolled in bed and dislocated his hip anteriorly.The liner and head were removed and replaced.An undisplaced fracture of the greater trochanter was noted to be a contributing factor.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.A photograph of the explanted liner identified that the liner was covered in bio debris.The rim was slightly damaged.No further evaluation could be performed with the image provided.An x-ray image was provided and identified the following: anatomic alignment of the right hip arthroplasty.No further evaluation was possible with the image provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• 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
• MDR Report Key: 10102031
• MDR Text Key: 193030739
• Report Number: 0002648920-2020-00281
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

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 Expiration Date: 04/21/2022
• Device Model Number: N/A
• Device Catalogue Number: 00801803201
• Device Lot Number: 62051566
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 06/01/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 105