MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC SL STEM HIP; N/A

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The manufacturer received x-rays and other source documents for review.The device has not been received for investigation as the patient has not been revised.As no lot number was provided, the device history records could not be reviewed.Attempts to obtain additional information have been made; however, no more is 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).Item and lot numbers unknown.

Event Description

It was reported that a patient underwent right thep on an unknown date and is being considered for revision surgery due to unknown reason.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event summary: it was reported that a patient underwent right thep on an unknown date and is being considered for revision surgery due to periprosthetic bone fracture.Review of received data xray: two x-rays have been received (one undated, one from (b)(6) 2019) and reviewed by hcps.Assessment of imaging: two views of the right hip demonstrate a right total hip arthroplasty with screw fixation of the acetabular cup.Subjectively, there is a normal acetabular inclination angle.There is a periprosthetic fracture involving the proximal right femoral diaphysis medial cortex with possible extension to the lateral cortex on the cross table lateral film.Mild osteopenia.Impressions: right total hip arthroplasty in place.Periprosthetic fracture involving the proximal right femur with involvement of the medial cortex of the proximal femoral diaphysis with possible extension to the lateral cortex.Overall fit and alignment of the implants is appropriate.There may be mild osteopenia.No signs of loosening, wear or radiolucency.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the involved device is intended for treatment.Conclusion summary: it was reported that a patient underwent right thep on an unknown date and is being considered for revision surgery due to periprosthetic bone fracture.It remains unknown whether the patient experienced any trauma which might have caused or contributed to the periprosthetic bone fracture.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the limited informationa available, we were not able to identify an exact root cause for this issue.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

It was reported that the patient had a tha in 1989.The patient had a revision surgery on (b)(6) 2019 due to a periprosthetic fracture after falling off a ladder.

• Brand Name: ALLOCLASSIC SL STEM HIP
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9260567
• MDR Text Key: 164843261
• Report Number: 0009613350-2019-00641
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other