MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 0DEG 30MM; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number NLS-300000B

Device Problems Degraded (1153); Nonstandard Device (1420); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414)

Event Date 10/15/2012

Event Type  Injury  

Event Description

It was reported that, through attorney for the pt, as a result of a legal claim, that allegedly the pt sustained injuries and complications stemming from her left hip implant.Update: dr (b)(6) states pt presented with increased pain in joint area, elevated chrome and cobalt serum levels, positive (b)(6) scan.

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock met specifications.The complaint history review indicated that there have been similar events for the reported family.The event was confirmed.A voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported event is considered to be under the scope of this recall.

Manufacturer Narrative

The event was confirmed.A voluntary recall (b)(4) was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported event is considered to be under the scope of this recall.

Event Description

It was reported that, through attorney for the patient, as a result of a legal claim, that allegedly the patient sustained injuries and complications stemming from her left hip implant.Additional information reported via sales rep 4/17/2013: dr.(b)(6) states patient presented with increased pain in joint area, elevated chrome and cobalt serum levels, positive mars scan.Update per medical review: "on (b)(6) 2013 an admission for a revision of the left total hip arthroplasty for a diagnosis of increased pain left hip is noted.The patient was sent for cobalt and chromium levels and was noted to have an increased cobalt level of 6.9.An mri revealed fluid accumulation and revision was planned.".

Manufacturer Narrative

An event regarding revision due to elevated cobalt level involving a rejuvenate modular device was reported.The event was confirmed through med review.Method & results: product evaluation and results: device evaluation was not performed as no devices were received.Clinician review: the provided medical information was submitted to a consulting clinician who stated that: "on (b)(6) 2013, an admission for a revision of the left total hip arthroplasty for a diagnosis of increased pain left hip is noted.The patient was sent for cobalt and chromium levels and was noted to have an increased cobalt level of 6.9.No x-rays are available for review and there is no pathologic confirmation or mri confirmation of "pseudotumor" or altr.There is no examination of the explanted components and no description of metallic debris around the stem or in the modular junction.The decrease in the serial serum cobalt levels from 8.8 on november i, 2012 to 5.5 on (b)(6) 2013, with normal chromium levels, adds further question to the diagnosis of al tr." "based upon the information reviewed there is no indication that the well-fixed total hip arthroplasty components that were revised in this case were the cause of the clinical situation described." product history review: review of device history records found the devices in the reported lot were accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there have been other events for the reported lot.Similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.Conclusions: it was reported that the patient was revised due to pain in joint area, elevated chrome and cobalt serum levels, positive mars scan.The provided medical information was submitted to a consulting clinician who confirmed increased cobalt level.Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported revision due to elevated cobalt level is considered to be under the scope of this recall.

• Brand Name: LRG TAP PRI MOD NCK 0DEG 30MM
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3608680
• MDR Text Key: 17388583
• Report Number: 9616680-2014-00230
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/27/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/22/2015
• Device Catalogue Number: NLS-300000B
• Device Lot Number: 34096101
• Other Device ID Number: 1009PCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2089/2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female