MAUDE Adverse Event Report: ZIMMER GMBH ORIGINAL M.E. MULLER, STEM, PT-S30, STRAIGHT, LATERAL, CEMENTED, 10.0, TAPER; MULLER STRAIGHT STEM FEMORAL PROSTHESIS

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the stickers with reference number and lot were missing inside the box.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Investigation results were made available.Dhr review: ref#: 35.00.39-100, lot#: 2935132.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: missing patient labels.Review of event description: it was reported that patient labels with reference number and lot were missing inside the box.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: no product was returned to zimmer biomet.Review of product documentation: a review of the dhr 2935132 shows that the lot 2935132 was packed and labeled between 06-feb-2018 and 09-feb-2018 in the finish department in zimmer biomet winterthur.It was reported that patient labels with reference number and lot were missing inside the box.No product was returned to zimmer biomet.Reviewing the device manufacturing quality records (dhr) indicates that the released components met all requirements to perform as intended.The lot 2935132 was packed and labeled between 06-feb-2018 and 09-feb-2018.A stock investigation of another released piece of the same lot in the warehouse in hazeldonk showed that no deviation could be found.Patient labels were inside the box.Based on the given information no precise conclusion can be made.However, most likely the missing patient labels were caused due to a manufacturing issue in the finish department in zimmer biomet winterthur.Based on the available information further investigation has been initiated to determine the necessity of potential corrective and/or preventive actions.Should the results of the further investigation indicate the necessity of a remedial action/corrective action/preventive action/field safety corrective action, an updated report will be submitted.Zimmer biomet's reference number of this file is (b)(4).

Event Description

No event update.

• Brand Name: ORIGINAL M.E. MULLER, STEM, PT-S30, STRAIGHT, LATERAL, CEMENTED, 10.0, TAPER
• Type of Device: MULLER STRAIGHT STEM FEMORAL PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7493610
• MDR Text Key: 107573473
• Report Number: 0009613350-2018-00502
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK923808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 35.00.39-100
• Device Lot Number: 2935132
• Other Device ID Number: 00889024417656
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 10/21/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1