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

Model Number N/A

Device Problems Material Erosion (1214); Compatibility Problem (2960)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: liner standard 3.5 mm offset 40 mm, pn 00630506040, ln unknown; unknown stem; unknown cup.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that patient underwent a left hip revision due to pain, elevated metal ions, and metallosis.The surgeon replaced the head and liner.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Photos of the explanted head and liner were received.Taper corrosion can be identified on the head.A femoral head and a poly liner were returned for evaluation.As returned, the femoral head has damage on the bottom surface near the taper.This damage most likely occurred during removal.The surface of the taper exhibits dark debris and a thread like pattern.The condition of the taper will not allow for an accurate dimensional analysis.The poly liner was returned with severe damage to the rim feature.Quantitative eds analysis confirmed the presence of biological tissue deposits on the chamfer of the head, along with metallic oxides containing the elements titanium (ti), vanadium (v), chromium (cr), cobalt (co), zirconium (zr) and molybdenum (mo).The metallic oxides are possibly corrosion products from the head and stem tapers.Eds analysis of uncontaminated areas of the taper bore was consistent with cocrmo alloy, with some minor contamination by organic material.The source of zirconium found in the eds analysis cannot be identified.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

Upon receipt of additional information it has been determined that the device was reported investigated on a different report, mfr 0002648920-2017-00077.Hence the initial report submitted needs to be voided.

Event Description

Upon receipt of additional information it has been determined that the device was reported investigated on a different report, mfr 0002648920-2017-00077.Hence the initial report submitted needs to be voided.

• 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
• 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: 6595412
• MDR Text Key: 76127016
• Report Number: 0002648920-2017-00310
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953337
• 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,Followup,Followup
• Report Date: 07/24/2019

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: Physician
• Device Expiration Date: 07/23/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801804002
• Device Lot Number: 61023051
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 05/02/2018; 06/24/2019
• Supplement Dates FDA Received: 05/03/2018; 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2008
• 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
• Patient Weight: 98