MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN MODULARER REVISIONS-HÜFTSCHAFT; HIP IMPLANT

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 06/27/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision of the hip due to failure/wear of the prosthesis.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Report source: foreign - germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided device is used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: proximal left femur demonstrates bone resorption at the level of the greater trochanter, likely chronic.There is also mild sclerosis of the lesser trochanter of the left femur, likely related to prior trauma.The left total hip arthroplasty otherwise appears grossly unremarkable with intact bone/hardware and no periprosthetic lucencies.The right arthroplasty is grossly unremarkable radiographically without obvious abnormal findings.Overall fit and alignment appears normal.Bone quality appears normal.No signs of loosening, wear, radiolucency, or other contributing fractures.Chronic bone resorption of the left greater trochanter.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.

• Brand Name: UNKNOWN MODULARER REVISIONS-HÜFTSCHAFT
• Type of Device: HIP IMPLANT
• 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: 15143545
• MDR Text Key: 297033293
• Report Number: 0009613350-2022-00400
• Device Sequence Number: 1
• Product Code: KWA
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 99 KG