MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 00801803603-femoral head sterile product do not resterilize 12/14 taper- 62167423; 00630505636- liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00261.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Reported event was confirmed.Visual review of the head identified dark debris on the taper surface.Sem analysis of the head identified the following: there were deposits on the taper surface and circumferential grooves, possibly from contact with the surface texture of the stem's taper.Light surface pitting were observed on the taper surface.Quantitative eds of the taper surface identified the following: biological material containing some or all of c, n, o, p, s, cl, and ca.Cocrmo substrate material showing elevated levels of cr, mo, and o, possible evidence of corrosion products.Titanium, possibly transfer from the stem taper.Polished bearing surface of the head was consistent with cocrmo alloy.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.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.Product remains implanted.

Event Description

It was reported that patient underwent a revision surgery approximately 8 years post implantation due to metallosis.During the procedure the surgeon did a liner and head exchange.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10430022
• MDR Text Key: 203636077
• Report Number: 0001822565-2020-02996
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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
• Report Date: 08/19/2020

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 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: 04/14/2020
• Initial Date FDA Received: 08/20/2020
• 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: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 56