MAUDE Adverse Event Report: ZIMMER GMBH AVENIR, STEM, STANDARD, CEMENTED, 2, TAPER 12/14; AVENIR CEMENTED HIP STEM

Model Number N/A

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Model #/lot # - additional device information: unique identifier (udi) # (b)(4).The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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 during a surgery, it was noticed that the patient label was missing.

Manufacturer Narrative

Investigation results were made available.Additional: if follow-up, what type, implant date.Correction: date of report, date rec¿d by mfr, pma/510k.Dhr review: 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 the patient labels were missing in the packaging.The customer had to cut the label out of the box.Devices analysis: no product was returned to zimmer biomet, the product has been implanted.Review of product documentation: a review of the dhr 2956568 shows that the lot: 2935132 was packed and labeled on 27-jul-2018 in the finish department in winterthur.Conclusion summary: it was reported that the patient labels were missing in the packaging.The customer had to cut the label out of 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: 2956568 was packed and labeled on 27-jul-2018.A stock investigation of another released piece of the same lot in the warehouse in italy 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 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: AVENIR, STEM, STANDARD, CEMENTED, 2, TAPER 12/14
• Type of Device: AVENIR CEMENTED HIP STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8019221
• MDR Text Key: 126540690
• Report Number: 0009613350-2018-01112
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K131884
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.202
• Device Lot Number: 2956568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1