MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Local Reaction (2035); Metal Related Pathology (4530)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a right total hip arthroplasty.Subsequently, the patient was revised approximately 6.5 years later due to metallosis, altr, psuedotumor and elevated ion levels.The head and liner were revised.There was some discoloration noted upon removing the head, the trunnion of the stem was darkened.The liner was damaged upon removal.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Photographs were provided.Visual review identified the following: the products were covered in bio-debris.There was discoloration in the head's taper and on the trunnion.No further evaluation could be performed with the images provided.The head was returned and visual evaluation of the head identified the following: there is dark debris in the taper.No other damage was noted.Sem analysis of the femoral head revealed the following: the taper of the returned device was reviewed via optical microscopy (magnification range 5x - 50x) using a keyence vhx-1000 digital microscope.The taper was assigned a modified goldberg score of 2.A score of 2 corresponds to 'fretting on >10% of the surface and/or corrosion damage to one or more small areas'.No further evaluation could be performed with the returned product.Review of the device history records identified no deviations or anomalies during manufacturing.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: FEMORAL HEAD 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: 11381721
• MDR Text Key: 233733223
• Report Number: 0002648920-2021-00033
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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: 00801803202
• Device Lot Number: 62747924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP; UNKNOWN ZIMMER AVINIR STEM; ZIMMER LINER CAT#00630505032 LOT#UNK; UNKNOWN CUP; UNKNOWN ZIMMER AVINIR STEM; ZIMMER LINER CAT#00630505032 LOT#UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 80