MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO5 CEMENTLESS RIGHT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 4845-0105

Device Problem Corroded (1131)

Patient Problems 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

"circumstances of occurrence / description of facts : 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).Reporting status: c clinical consequences noted : significant infiltration of the synovium and muscles by metallosis.Major risk of prosthetic instability - infectious risk.Conservative measures and actions taken : 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.".

Manufacturer Narrative

Reported event an event regarding corrosion involving a abg ii stem was reported.The event of corrosion was not confirmed while the metallosis, as a hazardous situation, was confirmed based on medical review.Medical review also suggested possible stem loosening in place but this failure mode is not confirmed.Method & results -product evaluation and results: damage on the returned cup and head is consistent with articulation wear damage.Damage on the neck of the stem is consistent with the explantation process.The eds and analysis showed that the cup base alloy was consistent with astm f136 and the stem base alloy was consistent with astm f1813, both components are consistent with their drawings.The debris on the proximal surface of the cup is consistent with material transfer from the head.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-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: evaluation of the returned devices revealed that damage on the neck of the stem is consistent with the explantation process.The eds and analysis showed that the stem base alloy was consistent with astm f1813, both components are consistent with its drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Metallosis was confirmed based on medical review.However, it cannot confirm that the stem contributes to the metallosis as stem corrosion was not confirmed.Medical review indicates that loosening of the stem was also a possibility but likely unrelated to the event.The exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

"circumstances of occurrence / description of facts : revision surgery planned following clinical observations on the 08/01/2020 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).Reporting status: c clinical consequences noted : significant infiltration of the synovium and muscles by metallosis.Major risk of prosthetic instability - infectious risk conservative measures and actions taken : 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 (b)(6) 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.[.]".

• Brand Name: ABGII NO5 CEMENTLESS RIGHT V40
• 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: 10307925
• MDR Text Key: 199986982
• Report Number: 0002249697-2020-01519
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327050943
• UDI-Public: 07613327050943
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• 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: 08/31/2021
• Device Model Number: 4845-0105
• Device Catalogue Number: 4845-0105
• Device Lot Number: G6087938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• 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