MAUDE Adverse Event Report: ZIMMER GMBH WEBER STUEHMER STEM GENERIC

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 07/21/2015

Event Type  Injury  

Event Description

It was reported, that the patient was implanted a weber stuehmer stem generic on an unknown date.The patient underwent a revision surgery due to aseptic loosening of the stem on an unknown date.

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.This information was taken from a medical journal article.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Manufacturer Narrative

Dhr review: the dhr check could not be performed as lot number was not available.Trend analysis: trend analysis could not be performed as no reference number was available.Compatibility check: the compatibility check could not be performed as no product information was provided.Review of incoming information: it was reported that an unknown patient was revised due to loosening.Unknown implantation and explantation time.No more details were provided about the event.No x-rays or pictures, surgical notes or other documents were provided.Devices analysis: no device analysis was performed as no product was available for investigation.Possible causes for the reported event: aseptic loosening due to inadequate cement mantle due to implant design.Not possible as according to the complaint summary an adverse trend due to inadequate design would have been detected.Aseptic loosening due to insufficient long term stability.Possible as patient factors that may affect the performance of the components such as bone quality, activity level, type of activity and relevant medical history were unknown.Therefore, it cannot be excluded.Aseptic loosening due to incorrect distribution of load due to design.Not possible as according to the complaint summary an adverse trend due to inadequate design would have been detected.Aseptic loosening: product with processing residuals leads to undesired tissue reaction due to auxiliary material residuals due to production residuals (quantity and biological reactivity).Design not suitable for washing process.Possible as neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implants were received; therefore the condition of the components is unknown.Therefore, it cannot be excluded.Aseptic loosening due to surgeon unfamiliar with implantation technique of this stem design (primary stability, e.G.Cementless implantation).Possible as neither x-rays, operative notes nor product were received.Therefore, it cannot be excluded.Aseptic loosening due to movement of implant against bone cement leads to wear.Possible as product was not returned for investigation and cannot be excluded.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 (b)(4) considers this case as closed.(b)(4).

• Brand Name: WEBER STUEHMER STEM GENERIC
• Type of Device: UNK
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4955919
• MDR Text Key: 6038063
• Report Number: 9613350-2015-00887
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention