MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZMR CALCAR B BODY 46X45MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Rash (2033)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # unknown unk proximal body stem lot # unknown.Reported event was confirmed upon review of photographic evidence as well as operative notes.Photographs indicate the fracture was just distal of the proximal body.Operative notes indicate confirms revision surgery due to fracture of the femoral component.Multiple fragments of osteonecrotic lamelar bone and fragments of viable cortical lamelar bone with viable bone marrow was noted.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.Multiple mdr's reports were filed for this event, please see associated reports: 0001822565 - 2018 - 02621 - 1.

Event Description

It was reported that patient underwent total hip arthroplasty approximately 5 years ago.Patient underwent revision approximately 2 years later due to pain/prosthetic/implant fracture.During revision bone with viable bone marrow was noted.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.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.

Manufacturer Narrative

(b)(4).Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b5; b6; b7; d2; d10; d11; g4; g5; h2; h3; h6.D11: 00998201818 ¿ zmr taper stem ¿ 62522365.Complaint sample was returned and evaluated against the reported event.Visual examination of the stem and cone body identified a fractured portion of the distal stem body still inside of the cone body.Gouges, nicks and bio debris were present on the stem and cone body.Sem analysis of the products revealed beach marks, consistent with fatigue failure mode on the surfaces of the products.The fracture surface artifacts suggests the fracture initiated on the lateral side of the stem.Possible axial wear marks were observed.Xrf analysis confirmed that the taper stems material was consistent with ti6-4 titanium alloy.Additional information does not change the final results of previous investigation.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

It was reported that patient had a ct scan approximately 2 years post left hip arthroplasty that noted a periprosthetic fracture and implant fracture.Approximately 5 days later, the patient underwent a revision surgery.During the procedure, a rash was noted over the buttocks and groin of the patient.Attempts have been made and additional information is unavailable at this time.

• Brand Name: ZMR CALCAR B BODY 46X45MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7602382
• MDR Text Key: 111140504
• Report Number: 0001822565-2018-03240
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K113296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/27/2020

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: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00999401845
• Device Lot Number: 60650584
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 07/03/2018; 10/02/2018; 07/24/2020
• Supplement Dates FDA Received: 08/02/2018; 10/04/2018; 07/27/2020
• 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: 57 YR