MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED, 14/225, TAPER 12/14; WAGNER SL REVISION STEM LATERAL

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.Pictures were received and will be reviewed as part of ongoing investigation.Device history record (dhr) was reviewed and no discrepancies were found.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 or Problem Description
It was reported that the outer packaging was completed but the inner sterile package was broken.The surgery was completed with another product.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
No change to previously reported even.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend considering the following event is identified: inner (sterile) packaging defect event summary: it was reported that two layers of the inner sterile packaging of the 14/225 wagner revision stem was found to be damaged.The outer packaging was intact.The surgery was completed with a 15/225 sl stem.Review of received data - the received photos confirm the reported event.It is visible that there is a rip in the bags, also in the sterile bag, exactly at the area where the bags were folded.Devices analysis - the visual examination shows that in all 3 layers of the bags there is a rip exactly at the area where the bags were folded.This hole is at the distal end position of the stem (tip of the stem).Further, no conspicuousness could be identified.Based on this visual examination the reported event can be confirmed.Review of product documentation - this device is intended for treatment.Conclusion summary it was reported that two layers of the inner sterile packaging of the 14/225 wagner revision stem was found to be damaged.The outer packaging was intact.The visual examination shows that in all 3 layers of the bags there is a rip exactly at the area where the bags were folded.This hole is at the distal end position of the stem (tip of the stem).The device manufacturing quality records were checked and indicates that the released components met all requirements to perform as intended.Based on the given information and the results of the investigation, we were able to identify a specific root cause for this issue.We could exclude that the package damage occurred during the packaging process and therefore it can be concluded that a wrong handling or transportation issue of the device has most likely led to the damaged packaging.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, a big scope of packaging configurations was changed in the year 2017 to optimize the design.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: WAGNER SL REVISION HIP STEM, UNCEMENTED, 14/225, TAPER 12/14
• Common Device Name: WAGNER SL REVISION STEM LATERAL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8324832
• Report Number: 0009613350-2019-00054
• Device Sequence Number: 1788906
• Product Code: LZO
• UDI-Device Identifier: 00889024485181
• UDI-Public: 00889024485181
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.00102.214
• Device Lot Number: 2830978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1