MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACETABULAR CUP; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Component Falling (1105); Crack (1135); Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 06/08/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.

Event Description

Failed left total hip arthroplasty.Recent fall prompted acetabular component revision.A revision of the acetabulum with allograft of the medial wall was performed.Acetabulum was grossly loose, cracked through medial cortex.A stryker titanium revision cup with four screws, a 36/10 head were inserted.

Manufacturer Narrative

An event regarding a revision of a grossly loose acetabulum, cracked through the medial cortex involving an unknown shell was reported.The event was confirmed.Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.Medical records received and evaluation: the clinical review of the operative reports documented a recent fall and failed left total hip arthroplasty requiring a revision of the acetabulum with allograft of the medial wall.The operative report notes the acetabulum was grossly loose, cracked through medial cortex.60cc¿s of cancellous graft was impacted and a stryker titanium revision cup with four screws, a 36/10° insert, and a 36/0 head were inserted by uncomplicated surgery.Device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: although the exact cause of the event could not be determined based on the medical review performed and information contained within the investigation the recent fall may have led to or contributed to the failed left total hip arthroplasty requiring revision.There is no evidence that factors of faulty component design, manufacturing or materials are responsible for the clinical problems.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Failed left total hip arthroplasty.Recent fall prompted acetabular component revision.A revision of the acetabulum with allograft of the medial wall was performed.Acetabulum was grossly loose, cracked through medial cortex.A stryker titanium revision cup with four screws, a 36/10 head were inserted.

• Brand Name: UNKNOWN ACETABULAR CUP
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5209632
• MDR Text Key: 30685990
• Report Number: 0002249697-2015-03679
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

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 Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 71