MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LRG TAP PRI MOD NCK 8DEG 34MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number NLV-340800G

Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/01/2014

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 two 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.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 pain is considered to be under the scope of this recall.No further investigation is required.

Event Description

Per medical records in pi, rejuvenate stem and neck was revised to restoration modular stem and body due to metal on metal reaction.Update: - (b)(6) 2013 rejuvenate modular hip was revised to restoration modular due to increasing pain and increased metal ions.

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 two 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.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 pain is considered to be under the scope of this recall.No further investigation is required.

Event Description

Per medical records in pi, rejuvenate stem and neck was revised to restoration modular stem and body due to metal on metal reaction.Update: - (b)(6) 2013 rejuvenate modular hip was revised to restoration modular due to increasing pain and increased metal ions.

Manufacturer Narrative

Reported event: an event regarding abnormal ion levels involving a rejuvenate modular device was reported.The event was not confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Device 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.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: a revision surgery of a rejuvenate stem ((b)(6) 2013) can be confirmed but increased metal levels at that time cannot be confirmed.A subsequent revision can be confirmed for recurrent dislocation ((b)(6) 2014, note: the stated existence of metallosis and poor tissues at the prior revision was not confirmed).A third revision ((b)(6) 2021) can also be confirmed during which component to component impingement was noted with notching of the femoral neck and some metallosis in the tissues.Additional medical records would be required to define the event further.Root cause: the root cause of the first revision was pain and concern with the association of a recalled implant.Stated increased metal level could not be confirmed.The root cause of the second revision was instability.The root cause of the third revision cannot be ascertained without additional medical records.That said, impingement and notching of the femoral neck was noted at the time of the revision and this could certainly explain the concern and/or finding of increased metal levels (if confirmed) and metallosis.Conclusions 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 abnormal ion level is considered to be under the scope of this recall.No further investigation is required.

Event Description

Per medical records in pi, rejuvenate stem and neck was revised to restoration modular stem and body due to metal on metal reaction.Update: (b)(6) 2013 rejuvenate modular hip was revised to restoration modular due to increasing pain and increased metal ions.

• Brand Name: LRG TAP PRI MOD NCK 8DEG 34MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 13169363
• MDR Text Key: 286044469
• Report Number: 0002249697-2022-00021
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: NLV-340800G
• Device Lot Number: 37865501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male