MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Pain (1994); Local Reaction (2035); Reaction (2414)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products : unknown zimmer sz 54 trilogy cup, lot unknown.Zimmer trilogy liner 54x32 std cat#00-6305-050-32.Unknown zimmer sz 14 std beaded full coat stem, lot unknown.The device will not be returned for analysis, as the product was returned to the patient; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01976.

Event Description

It was reported the patient underwent an initial left tha approximately 6 years ago.Subsequently, the patient was revised to address pain, elevated ion levels and altr.The head/trunnion had corrosion.The head was removed and dark staining was noted.The liner was removed and damaged upon removal.Dark staining was observed on the neck of the stem.Cup and locking ring were checked and seemed fine.A new liner and head were implanted after some debridement and irrigation.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: h2; h3; h6.Reported event was confirmed by review of medical records received.Review of the available records identified the patient underwent a left total hip arthroplasty.Zimmer biomet components were placed without complications.The patient underwent a revision procedure due to failed hip arthroplasty.During the procedure, adverse local tissue reaction secondary to corrosion was noted.There was corrosion at the head-neck junction.Pseudotumor was debrided.There was osteolysis at shoulder of femoral implant/under collar.The head and liner were replaced with new zimmer biomet products.No other complications/ findings related to reported event were noted.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found 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.

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.The following sections were updated/corrected.Updated: b4, b5, g4, g7, h2, h3, h6, h10.The event was confirmed with photographs received.Visual examination of the photographs identified dark discoloration on the trunnion, and on the surface of the femoral head's taper.The liner was fractured and covered in biodebris.As reported, the liner was damaged during the removal of implants.No further evaluation could be performed with the images provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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 STERILE PRODUCT
• 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: 10119650
• MDR Text Key: 194172843
• Report Number: 0002648920-2020-00291
• 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,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 62568440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 26