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

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Reaction (2414)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: shell pn 00620005422/ ln unknown.Liner 10 degree pn 00631005032/ ln 60963079.Femoral body pn 00999301835/ ln unknown.Reported event was confirmed by review of medical records and device examination.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual evaluation of the head identified dark debris and a thread like pattern on the surface of the conical taper.No other damages were noted.Sem analysis of the head revealed deposits on the taper surface and circumferential grooves, possibly from contact with the surface texture of the stem's taper.Circumferential bands of deposits were observed in the taper.Axial wear or corrosion marks and surface pitting was noted.Quantitative eds of the taper's surface identified the following - 1) biological material containing some or all of c, na, o, p, s, cl, and ca.2) cocrmo substrate material showing elevated levels of cr, mo, and o, possible evidence of corrosion products.3) titanium, possibly transferred from the stem taper.Eds analysis of the polished bearing surface of the head was consistent with cocrmo alloy.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

It was reported that patient underwent total hip arthroplasty.The patient underwent a revision procedure seven years later due to pseudotumor, corrosion, pain, altr, necrosis, and an allergic reaction.Trunnion was acceptable, head was revised.No additional information is available.

• Brand Name: FEMORAL HEAD NON-SKIRTED 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
• 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: 10164324
• MDR Text Key: 195476241
• Report Number: 0002648920-2020-00307
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801803214
• Device Lot Number: 60975965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention