MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEUTRAL LINER 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Joint Dislocation (2374)

Event Date 02/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: head, pn 00801803602, ln 62161492.Stem (00-7713- 007-00, 62198172.Screw, pn: 00625006530, ln: 62273309.Shell, pn: 00875705201, ln: 62220475.Neck (00-7848-012-00, 62191309).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 a patient had an initial right tha.Subsequently the patient was revised approximately 5 years post implantation due to infection, recurrent instability and dislocation, elevated metal ion levels, tissue damage, pseudotumor/pseudocapsule, pain, swelling, bone remodeling, necrosis, and in-vivo corrosion.It was decided to do a two-stage revision with antibiotic cement spacer.Attempts were made to obtain additional information; however, none was available.Medical records indicated: superficial soft tissues noted to be fairly edematous; when the fascia was opened, a large amount of clear yellow fluid was expressed; brown material visualized consistent with pseudotumor formation; no joint capsule visualized; erosion into the greater trochanter; abductor muscles were completely gone; greater trochanter was bald with brown appearing tissue that appeared necrotic; excess bone formation around the proximal femur.

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: b4, g4, g7, h2, h3, h6, h10.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.Review of the sterility certificates confirmed that the products were sterilized per specifications.A definitive root cause could not be determined with the information 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.

• Brand Name: NEUTRAL LINER 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9446350
• MDR Text Key: 182144493
• Report Number: 0001822565-2019-05222
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K120370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00885101036
• Device Lot Number: 62208586
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• 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 Age: 63 YR