MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 22/200; HIP PROTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 06/13/2022

Event Type  Injury  

Event Description

It was reported that implant was broken.The patient had turned on the spot, then felt a crack in the hip joint.Patient outcome is unknown.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Foreign germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D10: revitanâ®, proximal part, cylindrical, uncemented, 95, taper 12/14, item# 01.00402.095, lot# 2774766.Product evaluation: no product was returned or pictures provided: product evaluation could not be performed.Device history record (dhr) review: review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fracture of the right femoral implant as noted possibly resulting from an aggressive twisting injury.Bone quality shows marked ssteopenia.The complaint reports a fracture of the revitan shaft while patient turned on the spot.On item was a field safety notice was provided to emphasize that patient selection for modular hip revision systems is a key parameter and bone stock of adequate quality must be present and appraised at the time of surgery.The product at hand was implanted prior to this field action.As reported in the medical records review, the patients shows bone quality markedly osteopenic.The condition of the patient at the moment of the surgery might be a contributor factor to the adverse event.However, no further data are available and the product was not returned for evaluation.Therefore, with the given information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: REVITAN, DISTAL PART, CURVED, UNCEMENTED, 22/200
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15128432
• MDR Text Key: 296848012
• Report Number: 0009613350-2022-00397
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024593077
• UDI-Public: (01)00889024593077(17)190930(10)2777255
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 01.00406.222
• Device Lot Number: 2777255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 91 KG