MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L FEMORAL STEM NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: femoral head sterile product do not resterilize 12/14 taper, pn 00801803601, ln 63135616, liner neutral 36 mm i.D.Size ii for use with 52 mm o.D.Size ii shell, pn00875101036, ln 63005769, bone scr 6.5x30 self-tap, pn 00625006530, ln 63098575, shell with cluster holes porous 52 mm o.D.Size ii for use with ii liners, pn 00875705201, ln 63034780.Multiple mdr reports were filed for this event, please see associated reports 0002648920-2019-00783, 0001822565-2019-04613.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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, prior to the revision procedure, pre-revision work up revealed elevated metal ions, and fluid at joint by mars magnetic resonance imaging.Revision of head & liner performed.Surgeon noted black rim at head/neck juncture and osteolysis at femur; however, the femur was not noted to be loose.Surgeon¿s plan indicated treating patient for presumed infection.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  medical records were provided and review.Review of the revision operative notes confirms that the patient underwent revision hip arthroplasty on (b)(6) 2017.Lab tests prior to revision shows elevated ion levels.Revision notes states no loosening or malposition noted.Osteolysis proximal femur appx 7mm, did not interfere with stability of stem.Notes black rim at head- neck taper.Removed liner & head & implanted new liner & head.Treating with presumed diagnosis of infection, picc line placed, iv vanco for 6 weeks, with id dr.Blum.Specimens intraop: multiple tissue/specimens collected.Leukocyte esterase positive +1.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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: M/L FEMORAL STEM NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9252190
• MDR Text Key: 164660726
• Report Number: 0001822565-2019-04643
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K032726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• 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: 00771101220
• Device Lot Number: 63026820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2020
• 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 Age: 64 YR