MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK OFFSET SIZE 13; PROSTHESIS, HIP

Model Number N/A

Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Information (3190)

Event Date 10/22/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, unknown versys head, lot #: unknown.Item #: unknown, unknown liner, lot #: unknown.Item #: unknown, unknown cup, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00789 head.

Event Description

It was reported by patients¿ legal counsel that the patient underwent a hip arthroplasty and was then revised four months later for unknown reasons.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Event Description

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

Event Description

It was reported that the patient underwent an initial right total hip arthroplasty and was revised four months later due to pain and femoral periprosthetic fracture.During revision, a fracture was noted below the lesser trochanter with subsequent loosening of the stem.The femoral stem and head were replaced without complication.Cerclage wires were placed for fracture stabilization.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D11: 00875705401, lot 62344009 continuum shell 54mm.00801803602 lot 62352891n vesys head 36mm+0.00875201136 lot 62202894 continuum liner.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6 reported event was confirmed by review of medical records and radiographs.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records were provided and reviewed by a health care professional.The patient underwent an initial right tha for osteoarthritis; there were no intraoperative complications noted.Postoperative xrays demonstrate satisfactory alignment without fracture.The patient underwent a revision surgery due to pain and femoral periprosthetic fracture.When explanting, the stem showed signs of loosening.Cerclage wires were used for prophylactic stabilization.The head and stem were replaced without complication.From the radiology reports provided, the preop xray results were consistent with periprosthetic fracture.There was a tiny linear defect noted within the stem at the level of the medial cortical periprosthetic fracture.Postop xray results showed wire suture stabilization and fixation of the periprosthetic fracture.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 STEM PRESS-FIT COLLARLESS 12/14 NECK OFFSET SIZE 13
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9807011
• MDR Text Key: 190462641
• Report Number: 0001822565-2020-00792
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K051491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00786401320
• Device Lot Number: 62303231
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention