MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN POLY LINER; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Corrosion of the stem-head interface with subsequent re-coupling and metallosis.

Manufacturer Narrative

An event regarding corrosion of the stem-head interface of a tha was reported.Upon evaluation of the returned devices, damage involving an unknown poly liner was identified.The event was confirmed through return of the device.Method & results: -device evaluation and results: damage consistent with explantation was observed on the proximal and articulating surfaces of the liner.Damage consistent with contact against the hip stem was also observed.Debris was observed on the articulating surface of the liner; this debris was analyzed further using a sem.The adhered material on the liner was consistent with material transfer from the stem, biological material, and an oxide.Scratching and yellow discoloration were observed on the articulating surface of the acetabular insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.- medical records received and evaluation: the provided medical records were provided to a clinician and subsequently deemed insufficient for medical review.The clinician indicated: need operative reports, clinical and past medical history, serial x-rays and pathology reports.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: damage consistent with explantation was observed on the proximal and articulating surfaces of the liner.Damage consistent with contact against the hip stem was also observed.Debris was observed on the articulating surface of the liner; this debris was analyzed further using a sem.The adhered material on the liner was consistent with material transfer from the stem, biological material, and an oxide.Scratching and yellow discoloration were observed on the articulating surface of the acetabular insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Corrosion of the stem-head interface with subsequent re-coupling and metallosis.

• Brand Name: UNKNOWN POLY LINER
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8574761
• MDR Text Key: 143870278
• Report Number: 0002249697-2019-01833
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR