MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO4 CEMENTLESS LEFT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 4845-0204

Device Problems Contamination (1120); Insufficient Information (3190)

Patient Problems Inflammation (1932); Toxicity (2333); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)

Event Date 04/29/2016

Event Type  Injury  

Manufacturer Narrative

No additional information is available at this time due to ongoing litigation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

"hospital reported: "significant contamination to the serum chromium (still rising) and significant deficit at the functionality of the lower left limb " mentioned by patient's defense counsel that on (b)(6) 2016 asked for damages.In 2012, stryker has issued notice for voluntary recall dm stems and modular necks abgii and rejuvenate for metallosis described phenomena as well as for other clinical problems.We should be deepened if the metallosis complained in this case, if confirmed, may have been triggered by the type of prosthesis that the patient is a carrier wherefore is reason for reporting this and future updates that will follow." we are informing the hospital that in this case the agb ii stem is not modular, but the monolithic one.

Manufacturer Narrative

An event regarding elevated serum chromium levels and loss of functionality of the lower left limb was reported.The event was not confirmed.Method & results: -device evaluation could not be performed as no items were returned.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review indicated that all devices were accepted into final stock with no relevant reported discrepancies.-complaint history review found no other similar events have been reported for the subject manufacturing lot.Conclusions: a review of hms 5163 "spec.For tmzf¿alloy for surgical imp.Applications" indicates that chromium is not a constituent material of the abg ii stem.The exact cause of the event could not be determined based on the information provided.Further information such as the return of the device, patient medical records, pathology reports and x-rays are needed to complete the investigation for determining the root cause.No further investigation for this event is possible at this time.If additional information and/or the device becomes available, this investigation will be reopened.

Event Description

"hospital reported: "significant contamination to the serum chromium (still rising) and significant deficit at the functionality of the lower left limb" mentioned by patient's defense counsel that on (b)(6) 2016 asked for damages.In 2012, stryker has issued notice for voluntary recall dm stems and modular necks abgii and rejuvenate for metallosis described phenomena as well as for other clinical problems.We should be deepened if the metallosis complained in this case, if confirmed, may have been triggered by the type of prosthesis that the patient is a carrier wherefore is reason for reporting this and future updates that will follow." we are informing the hospital that in this case the agb ii stem is not modular, but the monolithic one.

• Brand Name: ABGII NO4 CEMENTLESS LEFT V40
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5784916
• MDR Text Key: 49249299
• Report Number: 0002249697-2016-02223
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

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: 04/30/2019
• Device Catalogue Number: 4845-0204
• Device Lot Number: G4082915C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2014
• 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): Hospitalization; Other