MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH UNKNOWN SCREW; HIP PROSTHESIS

Catalog Number UNKNOWN SCREW

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Failure of Implant (1924); Deformity/ Disfigurement (2360); Joint Dislocation (2374); Foreign Body In Patient (2687); Metal Related Pathology (4530)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: item#: 01.00191.250 ;lot#:2907502 ;item name: burch-schneider reinforcement cage new right 50; item#: unknown cup ;lot#: unknown ;item name: unknown cup; item#: unknown screw ;lot#: unknow ;item name: unknown screw.G2-foreign-germany.G2-other-bfarm# 03636/23.H3-other: device evaluation could not be performed as part# and lot# unknown.Also device location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00206, 0009613350-2023-00207, 0009613350-2023-00411.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.H3 other text : see h10.

Event Description

It was reported a patient with an extensive revision history underwent a revision with implantation of a burch-schneider support shell, due to a fracture of the posterior acetabular pillar.Subsequently, the patient experienced a traumatic fall and had a revision.During the surgery, macroscopic metallosis was noted with acetabular dislocation, loosening and posterior fracture of the burch schneider support shell, loosening of all screws, fracture of one screw, and the dorsal rim was found non-existent with a large defect centrally.Part of the fractured screw was left within the pelvic bone as it was noted the exposure time was too time consuming.Competitor product was implanted and the procedure was completed without complication.Due diligence is completed for this complaint; to date whatever additional information received has been captured in this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.H6 - investigation findings - malfunction observed.Investigation of this incident is currently ongoing.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.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.H6 - investigation findings: annex c (as investigated) : malfunction observed - c24.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.Of note is that patient consent was received.In the event that the products are returned, the complaint investigation will be re-assessed and updated.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of manufacturing records for the unknown cup and unknown screws cannot be performed without product identification.Devices are used for treatment.The surgical report for revision surgery was received and reviewed by the nurse review group (hcp) with the following potentially contributing factors of event: traumatic fall, prior surgery with burch-schneider support shell for fracture of the posterior acetabular pillar, hx dislocations, obesity.The following findings were observed by the nurse review group (hcp): metallosis of right hip with acetabular dislocation, loosening as well as fracture burch, schneider support shell, no evidence of infection, anterolateral modified approach, macroscopic metallosis, taper and stem well preserved, loosely dislocated cup with loosened cement residues imbedded in the cup region- not captured as cup/cement is unknown.All screws are loose and one screw is broken.¿broken piece if left in pelvic bone since exposure is too time consuming and not necessary here.¿ shell- posterior region fractured (¿in sense of a material fracture¿).The dorsal acetabular rim is non-existent, as is a large defect centrally.Insertion of cancellous bone and femoral wedge into the cranial acetabular area for defect.Reconstruction.One preoperative radiographic image and one intra-operative fluoroscopic image were provided and reviewed by hcp (mmi - radiologist) with the following assessment: coned-down image of the right hip rontal image of the lower pelvis and proximal to mid bilateral femurs.Image 1 displays disassociation of the acetabular cup component, in which the cup is turned almost 90 degrees in the clockwise direction.The femoral head component is subluxed superolateral to the acetabulum.Image 2 demonstrates subluxation of the femoral head component which is eccentrically positioned superolateral with respect of the acetabulum.The acetabular cup appears lucent and rotated slightly clockwise resulting in severe increased lateral inclination of the acetabular cup.The acetabular cup is not dislocated out of the native acetabulum.Fracture of the salvage plate and screws within the acetabulum is not radiographically detected on either image.Acetabular cup implant disassembly and abnormal alignment of the femoral component with respect of the acetabular component.This could be due to metallosis as described on the event/deficiency description, although this can not be confirmed radiographically (better evaluated with cross-sectional imaging).Observation of the cup in the intraoperative fluoroscopic image does not appear to be a compatible product for the ring according to the surgical technique.It can therefore be assumed that an off-label approach was used during implantation.Based on the given information and the results of the investigation, it is likely that the reported fall event directly caused or contributed to the reported event.Possible contributing factors are the patient's medical/surgical history.Of additional note is that the observation of the cup in the intraoperative fluoroscopic image does not appear to be a compatible product for the ring according to the surgical technique and zimmer biomet product compatibility list.It can therefore be assumed that an off-label approach was used during implantation.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 SCREW
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 17377834
• MDR Text Key: 319747251
• Report Number: 0009613350-2023-00408
• Device Sequence Number: 1
• Product Code: LPH
• 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,Followup
• Report Date: 09/01/2023

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 07/28/2023; 08/07/2023
• Supplement Dates FDA Received: 07/28/2023; 09/01/2023
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 85 KG