MAUDE Adverse Event Report: ZIMMER GMBH WAGNER STEMP HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: cls sportono cup, catalog# unknown; lot# unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed a cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

The product has been implanted and revised for 2 hips due to radiolucent lines around the stem.

Event Description

Please refer to report 0009613350-2019-00534.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: as no lot number was provided, the device history records could not be reviewed.Trend analysis: analysis could not be performed as no item number is available.Event description: it was reported that the product mentioned in the journal article has been implanted and revised for 2 hips on an unknown date due to radiolucent lines around the stem.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The applicable surgical technique describes all steps necessary prior and during implantation.However, as no surgical report is available, comparison of the surgical technique and the approach used could not be performed.Instruction for use (ifu) for endoprostheses lists general instructions, risk factors, sterilization instructions, storage and handling instructions.However, as no surgical report and no additional relevant information is available, comparison of the ifu and the approach applied could not be performed.Conclusion: it was reported that the product mentioned in the journal article has been implanted and revised for 2 hips on an unknown date due to radiolucent lines around the stem.The in vivo time of the device is unknown.The dhr check could not be performed as the lot number was not available.The compatibility check could not be performed as no product information was provided.The investigation results did not identify a non-conformance or a complaint out of box (coob).Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant were received; therefore the condition of the component is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(6).

• Brand Name: WAGNER STEMP HIP
• Type of Device: WAGNER STEMP HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8935230
• MDR Text Key: 155692364
• Report Number: 0009613350-2019-00534
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2019
• 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