MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOCLASSIC SL STEM 4 12/14

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 09/14/2010

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20, catalog# : 0100185145, lot# : 2394071.Therapy date: (b)(6) 2010.The manufacturer did not receive x-rays for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.(b)(4).

Event Description

Patient was implanted on the left side and underwent revision surgery due to loosening.

Event Description

No event update.Investigation results are now available.

Manufacturer Narrative

As the case at hand is a legal claim it is not suspected that the devices or additional information are being submitted for review.Zimmer gmbh winterthur legal department have already passed all information that was received from the lawyer, to our complaint handling department.By experience zimmer gmbh never gets more information except for the one that has been already covered in the final report.Patients¿ advocates only provide to zimmer gmbh as much information as they are willing to share to protect the rights of their clients.All information which has been provided for this particular case is already covered in the final report.Nevertheless, should additional information become available to us, a follow up report will be submitted.A technical investigation was not possible to be performed, as the device(s) were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.Review of event description: it was reported that the patient was implanted on (b)(6) 2007 and underwent revision on (b)(6) 2010 due to loosening.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Surgical report: the surgical report has been reviewed, however no conspicuous findings relevant to the reported event have been identified.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient was implanted on (b)(6) 2007 and underwent revision on (b)(6) 2010 due to loosening.In vivo time of the product is 2.11 years.Based on the investigation the reported event cannot be confirmed.The investigation did not identify a nonconformance or a complaint out of box (coob).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)(4).

• Brand Name: ALLOCLASSIC SL STEM 4 12/14
• Type of Device: ALLOCLASSIC SL STEM 4 12/14
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9443219
• MDR Text Key: 182152356
• Report Number: 0009613350-2019-00796
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024481121
• UDI-Public: 00889024481121
• Combination Product (y/n): N
• PMA/PMN Number: K030373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 2844
• Device Lot Number: 2370476
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• 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