MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA CERAMIC INSERT 32/41G 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 4930-6-041

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Reaction (2414); Metal Related Pathology (4530)

Event Date 05/26/2020

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

Revision surgery planned following clinical observations on the (b)(6) 2020 after the insertion of a pth on (b)(6) 2017.Pain with cracking.The scanner reveals bursitis with posterior calcification just behind the greater trochanter.After incision, an abundant blackish liquid was found, then the ceramic insert in multiple friable pieces (no head fractures, major corrosion of the stem and cup).Significant infiltration of the synovium and muscles by metallosis.Major risk of prosthetic instability.Infectious risk.Removal of as much ceramic as possible (many debris, impossible to remove everything) and of the muscle due to the risk of metallosis.Anapathic and bacteriological sampling of fluid, soft tissue and bone.Replacement of the prosthesis.

Event Description

Revision surgery planned following clinical observations on (b)(6) 2020 after the insertion of a pth on (b)(6) 2017.Pain with cracking.The scanner reveals bursitis with posterior calcification just behind the greater trochanter.After incision, an abundant blackish liquid was found, then the ceramic insert in multiple friable pieces (no head fractures, major corrosion of the stem and cup).Significant infiltration of the synovium and muscles by metallosis.Major risk of prosthetic instability.Infectious risk.Removal of as much ceramic as possible (many debris, impossible to remove everything) and of the muscle due to the risk of metallosis.Anapathic and bacteriological sampling of fluid, soft tissue and bone.Replacement of the prosthesis.*update on 20-oct-2020 based on medical review: "[.] (b)(6) 2017: ap pelvis x-ray: abg bilateral mild subsidence on right.[.] (b)(6) 2019: ? scout for ct/ap pelvis x-ray: abg bilateral mild subsidence on right, pedestal left, debris at trochanter.Possible stem loosening.[.] (b)(6) 2020: operative report: postoperative dx: fracture of ceramic insert resulting in revision.Patient had cracking and squeaking and peri-trochanteric calcifications.Planned initially for excision thereof.Insert fracture suspected during preoperative exam.Metallosis found.Synovectomy performed.Ceramic fractured, but head intact."major damage" at the stem and cup level.[.] intraoperative tissue samples were sent to pathology that documented the metal infiltration but did not show acute inflammation indicative of infection.[.]".

Manufacturer Narrative

An event regarding crack/fracture involving an alumina ceramic liner was reported.The event was confirmed based on provided photos.Method & results: product evaluation and results: the ceramic liner was not returned for evaluation but a photograph was provided.A photo showed surgical wound with significant metallosis and apparent ceramic debris.Another photo showed that explanted liner were fragmented into small pieces with large amount of dark/black tissues and blood with it.The event of crack/fracture is confirmed.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: the assessment was confirmed.Obtaining the implant may provide insight into the mechanism of failure.Loosening of the stem was also a possibility but likely unrelated to the event.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the provided photo showed surgical wound with significant metallosis and apparent ceramic debris.Clinician review revealed that the assessment was confirmed.Obtaining the implant may provide insight into the mechanism of failure.Loosening of the stem was also a possibility but likely unrelated to the event.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ALUMINA CERAMIC INSERT 32/41G 28MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10305597
• MDR Text Key: 200012900
• Report Number: 0002249697-2020-01518
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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: 09/30/2019
• Device Catalogue Number: 4930-6-041
• Device Lot Number: 49540101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR