MAUDE Adverse Event Report: ZIMMER BIOMET, INC. S1S HIP HEAD CEMENT MOLD 64MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 431198 151023 hip mold stem w/reinf 15x200, 431187 s1s hip neck adapter +6mm, palacos r+g 2x40g lot number 82984502.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device 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: 0001825034 - 2019 - 05501, 0001825034 - 2019 - 05502.

Event Description

It was reported that after a complicated course post left total hip arthroplasty, the patient underwent implantation of an antibiotic spacer.During the hospital stay, the patient experienced outward rotation and lengthening of the left leg.The patient underwent closed reduction under anesthesia due to subluxation of the cement spacer.The hip was reduced and the patient discharged without further complication.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records received.Review of the available records identified that after a complicated course post left total hip arthroplasty, the patient underwent implantation of a zb antibiotic spacer.During the hospital stay, the patient experienced outward rotation and lengthening of the left leg.The patient underwent closed reduction under anesthesia due to subluxation of the cement spacer.The hip was reduced and the patient discharged without further complication.It can be concluded that this was a full dislocation based upon the leg lengthening and external rotation that occurred which would have to happen outside of the cup (dislocation) rather than contained within the cup space (subluxation).Additionally, a subluxation is resolved by subtle motion and would likely not require sedation as a closed reduction for dislocation would.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: S1S HIP HEAD CEMENT MOLD 64MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9437106
• MDR Text Key: 169822143
• Report Number: 0001825034-2019-05500
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00830304621063
• UDI-Public: (01)00830304621063
• Combination Product (y/n): N
• PMA/PMN Number: K161166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: N/A
• Device Catalogue Number: 431185
• Device Lot Number: 816110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/17/2020
• 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