MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM CEMENTED STD. COLLAR; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Failure to Osseointegrate (1863); Migration (4003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref 00620005222 lot 63236986 trilogy shell 52mm, ref 00625006535 lot 63333305 screw 6.5x35mm, ref 00625006525 lot 63341510 screw 6.5x25mm, ref 00630505032 lot 63242898 longevity liner, ref 00785001220 lot 63071058 versys stem size 12, ref 00785901000 lot 63232872 versys distal centralizer, ref 00801803214 lot 62395861 versys femoral head 32mm+7.0, (stryker bioprep bone preparation kit ¿ not an implant).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 patient had initial right total hip arthroplasty.Subsequently, the patient was revised approximately 3 years later due to pain and aseptic loosening of the femoral stem with surrounding cortical remodeling.During the revision, it was noted that the stem had debonded and subsided within the femoral cement mantle.The stem, head, and liner were replaced with an arcos system.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of operative notes.Operative notes were reviewed by a health care professional which indicated the patient was revised due to pain and aseptic loosening of the femoral stem with surrounding cortical remodeling.Revision op note demonstrated that the stem debonding noted with subsidence within the femoral cement mantle, all cement removed.Shell well fixed and remained intact, liner replaced.Preoperative radiographs demonstrated cortical remodeling at the anterolateral portion of the distal tip of the stem.Two cables had been placed to avoid fracture given that the preoperative radiographs demonstrated cortical remodeling at the anterolateral portion of the distal tip of the stem.Dhr 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.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: FEMORAL STEM CEMENTED STD. COLLAR
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8938284
• MDR Text Key: 155796790
• Report Number: 0002648920-2019-00638
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K950312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

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 Model Number: N/A
• Device Catalogue Number: 00785001220
• Device Lot Number: 63071058
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/05/2019
• 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 Weight: 59