MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH MEDULLARY PLUG W/OUT DRAIN 5; CEMENT OBTURATOR

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: femoral stem 12/14 neck taper standard offset size 1 130 mm stem length catalog no#:00811400100 ; lot# 64521375.The manufacturer received x-rays and other source documents (case reports etc.) which will be reviewed as part of ongoing investigation.Lot numbers were received and the device history records were found to be conforming.The investigation of the case and the process of gaining necessary information is still ongoing.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

Patient was having a surgery on the left side and during the surgery the neck of the femur fractured.

Manufacturer Narrative

Investigation results were made available.Review of event description: it was reported that during surgery the neck of the femur was fractured.Review of received data: x-rays: ap and oblique views of the left femur on four separate images demonstrate a left total hip arthroplasty with cement fixation of the acetabular cup.Femoral head is oversized as compared to the acetabular cup.No radiolucency surrounding the acetabular cup.No radiolucency surrounding the femoral stem.Normal cement mantle.There does appear to be an oblique linear lucency extending from the tip of the femoral component to the lateral cortex of the mid-diaphysis of the left femur, concerning for a fracture.Possible extruded cement is noted posterior to the proximal femur on the frog leg lateral view.Patient data: it was reported that there were contributing conditions related to the event, but these information were not disclosed due to patient confidentiality.Product evaluation: no product was returned as it remains implanted.Therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Surgical technique: it was reported that the surgical technique for the product was not utilized during implantation.Allen bone plug sizers were used as recommended by the company.Product compatibility: the compatibility matrix on zb website (www.Productcompatibility.Zimmer.Com) does not indicate that weber plugs can be used instead of allen system.Both surgical techniques describe the use / measuring of the corresponding plug in a comprehensive way.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that during surgery the neck of the femur was fractured.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty with possible oversized femoral head.Question oblique periprosthetic fracture involving the left femur in the region of the tip of the femoral stem extending to the lateral cortex.No other findings related to the reported event were noted.It was reported that there were contributing conditions related to the event, but these information were not disclosed due to patient confidentiality.Further, it is also reported that he surgical technique for the product was not utilized during implantation.Allen bone plug sizers were used as recommended by the company.If and to what extend these two factors may have contributed to the event remains unknown.Based on the investigation the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, 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 switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

No event update.Investigation results are now available.

• Brand Name: MEDULLARY PLUG W/OUT DRAIN 5
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11854065
• MDR Text Key: 251659896
• Report Number: 0009613350-2021-00231
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• PMA/PMN Number: K830949
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3205
• Device Lot Number: 3009508
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization