MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 54 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Local Reaction (2035); Tissue Damage (2104)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref 00771301100 lot 61329199 stem size 11, ref 00620005422 lot 61374971 shell 54mm, ref 00630505036 lot 61369377 longevity liner 36mm 3.5mm offset, ref 00784800300 lot 61190313 kinectiv neck s, ref 00801803602 lot 61424867 versys head 36mm+0.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0002648920 - 2020 - 00007, 0001822565 - 2020 - 00047, 0001822565 - 2020 - 00048, 0002648920 - 2020 - 00042, 0002648920 - 2020 - 00043.

Event Description

It was reported patient underwent initial right total hip arthroplasty.Subsequently, the patient was revised approximately nine (9) year later due to pain, altr, pseudotumor, and elevated metal ion levels.During the revision, it was found that the acetabular shell was excessively anteverted with impingement of the femoral stem against the liner causing a fracture of the liner.Significant corrosion was noted on the femoral head and neck trunnion.The shell, liner, head, and neck were replaced without complication.No further event information available at the time of this report.

Event Description

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

Manufacturer Narrative

Reported event was confirmed with medical records provided.Revision op notes demonstrated that the patient was revised due to pain, altr, pseudotumor, and elevated metal ion levels.During the revision, it was found that the acetabular shell was excessively anteverted with impingement of the femoral stem against the liner causing a fracture of the liner.Significant corrosion was noted on the femoral head and neck trunnion.The shell, liner, head, and neck were replaced without complication.The torn gluteus medius tendon was also repaired.Review of the device history record(s) for identified no deviations or anomalies during manufacturing related to the reported event.Additional information does not affect the root cause.Root cause was unable to be determined.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: SHELL POROUS WITH CLUSTER HOLES 54 MM
• 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: 9707637
• MDR Text Key: 179311812
• Report Number: 0002648920-2020-00043
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: N/A
• Device Catalogue Number: 00620005422
• Device Lot Number: 61374971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 84