MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CLS STEM

Model Number N/A

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: unknown cup, catalog#: unknown; lot#: unknown.Therapy date: unknown.The manufacturer received x-ray and source documents for review.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.(b)(4).

Event Description

Patient was implanted on an unknown side and an implant enquiry was made as a part of surgery pre-planning to treat periprosthetic fracture.

Event Description

Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.Event description: product was implanted on unknown date.Implant inquiry was made as part of surgery pre-planning due to periprosthetic fracture.It was determined, that the stem might either be a stelkast dtw or a zimmer cls.Harm: s3 - bone fracture.Hazardous situation: patient's anatomy is exposed to excessive external forces postoperatively.Review of received data: due diligence: no further due diligence required as follow-ups were already performed, however, no information could be obtained.X-rays: based on the received undated x-ray, it can be confirmed that the patient's bone is fractured.Product evaluation: no product was returned for an investigation.No information is available, that the revision surgery has been 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.Conclusion: product was implanted on unknown date.Implant inquiry was made as part of surgery pre-planning due to periprosthetic fracture.It was determined, that the stem might either be a stelkast dtw or a zimmer cls.Based on the investigation the reported event can be confirmed.The received x-ray confirms the periprosthetic bone fracture.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 non-conformance or complaint out of box (coob).Based on the limited available 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: CLS STEM
• Type of Device: CLS STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10117959
• MDR Text Key: 193941544
• Report Number: 0009613350-2020-00233
• Device Sequence Number: 1
• Product Code: LZO
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 03/26/2021
• 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