MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SELEX/MAGNUM MOD HD 40MM STD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Necrosis (1971); Pain (1994); Joint Dislocation (2374)

Event Date 09/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: ep-107825, e-poly 40mm maxrom lnr sz25, 763440; 51-104160, tprlc 133 t1 pps ho 16x152mm, 2643521; 16-116060, rnglc+ ltd hole shell sz60, 628180; 103533, ti low profile screw 6.5x30mm, 687400; 103532, ti low profile screw 6.5x25m, 333630.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-00837, 0001825034-2019-00911, 0001825034-2019-00912.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 that patient underwent a right hip revision procedure approximately 3 years post-implantation due to heterotopic ossification, pain accompanied with a limp, popping, grinding and feeling of subluxation.The ossification lead to impingement resulting in poor motion.It was further reported that the heterotopic ossification may have been the source of pain and audible noise.Two areas of ossification, corrosion, pseudotumor, necrotic tissue and debris were removed.Additionally, small amount of poly wear was noted.Liner and head were revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Dhr was reviewed and no discrepancies 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.

Event Description

No further event information available at the time of this report.

• Brand Name: SELEX/MAGNUM MOD HD 40MM STD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8377601
• MDR Text Key: 137378219
• Report Number: 0001825034-2019-00839
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: N/A
• Device Catalogue Number: S001140
• Device Lot Number: 937410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2019
• 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 Weight: 127