MAUDE Adverse Event Report: ZIMMER GMBH REVITAN PROXIMAL STEM HIP; N/A

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy date detail of product: item # unknown, item name revitan distal stem hip, lot # unknown.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.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.(b)(4).Item and lot numbers unknown.

Event Description

It was reported that the patient was implanted with a revitan stem (proximal & distal part) in the right hip.Patient underwent a revision of the wound with hip joint puncture on (b)(6) 2017 due to wound healing disorder.In the revision of (b)(6) 2017, the implants were not removed.

Manufacturer Narrative

Investigation results were made available.As the case at hand is a legal claim it is not suspected that the devices or additional information are being submitted for review.Zimmer gmbh winterthur legal department have already passed all information that was received from the lawyer, to our complaint handling department.By experience zimmer gmbh never gets more information except for the one that has been already covered in the final report.Patients¿ advocates only provide to zimmer gmbh as much information as they are willing to share to protect the rights of their clients.All information which has been provided for this particular case is already covered in the final report.Nevertheless, should additional information become available to us, a follow up report will be submitted.A technical investigation was not possible to be performed, as the device(s) were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.Note: this complaint was entered while reviewing additional information of complaint (b)(4).Dhr review: as no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device information has been requested but was not available at zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Trend analysis: analysis could not be performed as the item numbers are not available.Review of event description : it was reported that the patient was implanted with a revitan stem in the right hip on (b)(6), 2017.Consequently, patient underwent open wound examination and hip joint puncture on (b)(6), 2017 due to wound healing disorder.The implants remained in-situ.Review of received data: - in total 7 x-rays ((b)(6)) have been received.However, the x-rays do not cover the time period of the reported event.Therefore, no evaluation of the x-rays was performed.- discharge summary, dated (b)(6) 2017: in-patient from (b)(6) 2017 until (b)(6) 2017 surgery on (b)(6) 2017 therapy: revision right hip, transfemoral, removal of revitan tep using ems chisel, bacteriology.Revision to revitan stem.Anamnesis: patient potentially allergic to targin.Bacteriology: at the time of discharge all drawn bacteriological samples were steril.Histology: no morphological correlate of infection.- discharge summary, dated (b)(6) 2017: in-patient from 07 sep 2017 to (b)(6) 2017 surgery on (b)(6) 2017 diagnosis: wound healing disorder of distal wound lateral thigh with punctual bloody secretion after revitan revision due to revitan sintering on (b)(6) 2017.Therapy: open wound examination and hip joint puncture right procedure: frequent wound inspection.Removal of wound closure material 3 weeks post op.Presentation 3 weeks post op to remove sutures.Anamnesis: patient presents with redness and minimal secretion in the lower area of the surgical incision.Otherwise, patient feels well and is satisfied with the post op course after revision surgery ((b)(6) 2017).Patient is mobile and has hardly any pain.Surgical incision is unremarkable.Extension/flexion 0/0/110°.The x-rays (pelvis overview, hip axial right; x-rays have not been received) of (b)(6) 2017 show a correctly aligned implant without signs of loosening or sintering.Devices analysis: no product was returned to zimmer biomet for in-depth analysis, as all products remained in-situ.Review of product documentation: - all involved devices are intended for treatment.- compatibility: compatibility check could not be performed due to missing product identification.- the manufacturing documentation could not be pulled and reviewed due to missing product identification.Conclusion summary: the patient underwent a revitan revision in the right hip on (b)(6) 2017.Consequently, patient presents with redness and bloody secretion in the distal area of the surgical incision.An open wound examination and a hip joint puncture was performed on (b)(6), 2017 due to wound healing disorder.The implants remained in-situ, therefore, product investigation could not be performed.Due to missing product identification the manufacturing documentation could not be pulled and reviewed.Based on the missing product identification the compatibility check could not be performed.In conclusion, based on the given information an involvement of the implants in the reported event seems unlikely.It is probable, that the reported wound healing disorder is related to a patient condition.Nevertheless, a specific root cause could not be found based on current available data.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

No event update.

• Brand Name: REVITAN PROXIMAL 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: 8904961
• MDR Text Key: 154688944
• Report Number: 0009613350-2019-00505
• Device Sequence Number: 1
• Product Code: KWA
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 112