MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC SL STEM 4 12/14; ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: item# 2844, lot# 2930955, alloclassic sl stem 4 12/14.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 manufacturer did not receive other source documents for review.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.(b)(4).

Event Description

It was reported that patient labels were not included in this product package.The event happened during surgery; however, no adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: missing patient label.Event description: it was reported that patient labels were missing in the product packaging.Nevertheless, the product was implanted.Review of received data: no other case-relevant documents received.Device analysis: no product was returned to zimmer biomet review of product documentation: a review of the dhr shows that the lot was packed and labeled on 13-jan-2018 in the finish department in winterthur.Conclusion: it was reported that patient labels were missing in the product packaging.Nevertheless, the product was implanted.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 2930955 was packed and labeled on 13-jan-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.However, similar events has already been reported within complaint (b)(4) and (b)(4).The capa ca-05120 has been opened to treat this matter 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).

Event Description

Please refer to report 0009613350 - 2019 - 00274.

• Brand Name: ALLOCLASSIC SL STEM 4 12/14
• Type of Device: ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8560038
• MDR Text Key: 143398006
• Report Number: 0009613350-2019-00274
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 2844
• Device Lot Number: 2930955
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 08/14/2019
• Supplement Dates FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1