MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 132 SIZE 8 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 1601-08132

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Reaction (2414); Reaction to Medicinal Component of Device (4574)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral on her left hip on or about (b)(6) 2015 and the femoral head was explanted on (b)(6) 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral on her left hip on or about (b)(6) 2015 and the femoral head was explanted on (b)(6) 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.

Manufacturer Narrative

An event regarding abnormal ion level involving an unknown securfit stem was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "8/19/15 op report "left total hip arthroplasty" diagnosis""left hip osteoarthritis" gen.Anesthesia/ post-lateral approach.".52 cup.Size 8 stem.Crack noted in calcar.Dall-miles cable around proximal femur.+12 femoral neck.Patient tolerated procedure well." 28 head and x-3 insert.No clinical or pmh, no patient demographics, no imaging studies, no laboratory or pathology reports, no examination of explanted components, no revision operative report.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case." -product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the customer was inquiring if the reported device is subject to a recall.Based on the review, none of these reported products have been involved in a recall.The exact cause of the event could not be determined because insufficient information was provided.¿ additional information including operative reports, clinical or patient medical history (pmh), patient demographics, imaging studies, laboratory or pathology reports, and examination of explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: 132 SIZE 8 SECUR-FIT ADVANCED STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9533592
• MDR Text Key: 182180109
• Report Number: 0002249697-2019-04139
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

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 Expiration Date: 12/31/2018
• Device Catalogue Number: 1601-08132
• Device Lot Number: MMRV88
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR