MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ABGII MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problems Corroded (1131); Device-Device Incompatibility (2919)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.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 corrosion is considered to be under the scope of this recall.No further investigation is required.Device not returned.

Event Description

Abg 2 modular revision of left hip.Update spoke to rep.Intra-operatively, corrosion was noted at the stem/ neck interface.The trunnion had no wear, damage, or corrosion with the junction of the ceramic head.The stem construct, head, and poly liner were revised.Rep confirmed there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding corrosion involving a abgii modular device was reported.The event was confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Device history review: not performed as no lot was provided.Complaint history review: similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.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 corrosion is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned.

Event Description

Abg 2 modular revision of left hip.Update spoke to rep.Intra-operatively, corrosion was noted at the stem/ neck interface.The trunnion had no wear, damage, or corrosion with the junction of the ceramic head.The stem construct, head, and poly liner were revised.Rep confirmed there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN ABGII MODULAR NECK
• 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: 10501774
• MDR Text Key: 205964065
• Report Number: 0002249697-2020-01807
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2090-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 73 YR