MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP 10MM HUM FRAC STEM MACRO; SHOULDER, PROSTHESIS

Catalog Number 11-113560

Device Problem Migration (4003)

Patient Problem Rupture (2208)

Event Date 10/10/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: palacos r + g (1x40) cat: 66022663 lot: 71944266.Comp locking screw 4.75x25mm cat: 180502 lot: 203140.Comp rvrs shdr glen bsplt +ha cat: 115330 lot: 610100.Comp rvs hmrl ti tray 44mm cat: 115340 lot: 118380.Comp locking screw 4.75x20mm cat: 180501 lot: 919330.Versa-dial/comp ti std taper cat: 118001 lot: 101950.Comp locking screw 4.75x15mm cat: 180500 lot: 253770.Comp 10mm hum frac stem macro cat: 11-113560 lot: 341250.Comp locking screw 4.75x15mm cat: 180500 lot: 526050.Comp rvs cntrl screw 6.5x30mm cat: 115382 lot: 919450.Arcom xl 44-36 std hmrl brng cat: xl-115363 lot: 598840.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that the patient underwent a revision procedure due to humeral component loosening.It was noted that the patient had an anterior deltoid rupture that was repaired at the same time.No further information is available.

Manufacturer Narrative

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.

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.Reported event was confirmed by review of medical records.Review of the available records identified the following: initial hemiarthroplasty operative notes noted patient fell on left arm, sustained multipart proximal humerus fracture.No complications or blood loss.Revision operative notes noted non-healing.Intraoperative cultures were positive for p.Acnes.The patient was treated with an extended course of iv antibiotics.Removed hemiarthroplasty product and implanted of zb comprehensive.The patient continued to experience left humeral pain.X-rays demonstrated lucencies of the cement bone interface and loosening of the humeral stem component.The patient underwent a second revision of the left shoulder.Op notes noted anterior deltoid failure, humeral component found to be loose intraop with manual rotation, no sign of pus or infection.Cement and restrictor removed, new humeral stem cemented in without further complication.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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: COMP 10MM HUM FRAC STEM MACRO
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8873215
• MDR Text Key: 153650435
• Report Number: 0001825034-2019-03493
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2019

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: 08/01/2021
• Device Catalogue Number: 11-113560
• Device Lot Number: 341250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 08/27/2019; 11/26/2019
• Supplement Dates FDA Received: 09/19/2019; 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 102