MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSYS FM HD 28X-3.512/14; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Fall (1848); Inflammation (1932); Pain (1994); Synovitis (2094)

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown; unknown shell, unknown; unknown; unknown liner, unknown; unknown; unknown stem, unknown.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, [product location unknown].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient's right hip was revised approximately 6 years post implantation due to pain, reactive synovitis and fractured ceramic head.Approximately 3 weeks prior to revision, the patient heard a breaking sound, felt intense pain, then slipped and fell.During the revision, multiple irregular fragments of tan-yellow ceramic material grossly consistent with a femoral head component were found throughout the patient's wound.The surgeon proceeded with an extensive synovectomy to try and remove embedded shards from within soft tissues.Dense connective tissue with reactive fibroblastic and vascular proliferation, inflammation, and scratches on the proximal femoral component were noted.The shell, head and liner were revised.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following sections have been updated: reported event was confirmed by review of xrays received and revision operative notes.Device history record (dhr) was reviewed with no deviations.The root cause of the reported event cannot be determined with the information available.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: VERSYS FM HD 28X-3.512/14
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7866543
• MDR Text Key: 119921827
• Report Number: 0001822565-2018-04775
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

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: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 00-6428-028-01
• Device Lot Number: 61601781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2010
• 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 Age: 48 YR
• Patient Weight: 88