MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METABLOC STEM

Model Number N/A

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not received x-rays for review.Other documents (list of complications, email)were received and will be reviewed as part of ongoing investigation.As no lot number was provided, the device history records could not be reviewed.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

(b)(4) is created to capture the intra-operative complication that occurred during a clinical study.There are 23 intra-operative complications that have occurred complication severity: mild.7 patients experienced greater trochanter fracture which was resolved by tension band.13 patients experienced calcare fracture which was resolved by tension band complication severity: moderate 1 patient experienced distal femoral fracture, the bones are realigned and resolved with plates.1 patient experienced acetabular fracture, which was resolved by the exchange of the cup.1 patient experienced femoral fracture, the bones are realigned resolved with plates.

Event Description

No event update.Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.Review of event description: it was reported that the events have occurred on unknown dates.They are a part of an ongoing retrospective study on the metabloc stems.Patient have experienced intra-operative and post-operative complications.There have been 91 complications, 23 intra-operative and 68 post-operative complications.The 68 post-operative complications are as follows: 20 patients experienced dislocation, which was corrected by reduction revision surgery.12 patient were suspected for infection, which was treated with antibiotic therapy, dair and revision of implant.3 patients were reported to have pseudotumor which was treated with revision of acetabular component.Due to fall, 8 patients underwent revision surgery due to periprosthetic fracture (patients were also treated with osteosynthesis).20 patients underwent revision surgery due to aseptic loosening.5 patients underwent revision surgery due to pain.The 23 intra-operative complications that have occurred are as follows, complication severity: mild.7 patients experienced greater trochanter fracture which was resolved by tension band.13 patients experienced calcare fracture which was resolved by tension band complication severity: moderate.1 patient experienced distal femoral fracture, the bones are realigned and resolved with plates.1 patient experienced acetabular fracture, which was resolved by the exchange of the cup.1 patient experienced femoral fracture, the bones are realigned resolved with plates.Post operative complications captured under (b)(4) and intra operative complications (b)(4).Review of received data: due diligence: no further ""due diligence"" required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Dhr review: the dhr check could not be performed as the lot number was not available.Conclusion: it was reported that the events have occurred on unknown dates.They are a part of an ongoing retrospective study on the metabloc stems.Patient have experienced intra-operative and post-operative complications.There have been 91 complications, 23 intra-operative and 68 post-operative complications.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or 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).

• Brand Name: METABLOC STEM
• Type of Device: METABLOC STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11392250
• MDR Text Key: 249317834
• Report Number: 0009613350-2021-00110
• Device Sequence Number: 1
• Product Code: KWY
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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 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
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization