MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 21MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-221; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-221
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Sales rep reported that a patient underwent a revision surgery due to possible trunnionosis.The original case took place in 2008.
Event or Problem Description
Sales rep reported that a patient underwent a revision surgery due to possible trunnionosis.The original case took place in 2008.
Additional Manufacturer Narrative
An event regarding fretting involving a restoration modular body was reported.The event was confirmed through material analysis of the returned device.Method & results: -product evaluation and results: damage was observed on the stem neck and trunnion consistent with loss of taper lock.Biological material was observed on anterior, posterior, and superior surfaces.Damage consistent with the explantation process was observed on the inferior and superior surfaces.Debris was observed on the superior surface of the neck.Nothing noteworthy was observed on the screw; x-ray fluorescence spectroscopy (xrf) was performed to confirm the material.The mar concluded: damage was observed on the stem neck and trunnion consistent with the loss of taper lock.The damage present on the articulating surface of the insert is consistent with burnishing, scratching and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration on the liner is consistent with absorption of synovial fluid.Elemental analysis showed that all metallic components were consistent with their respective drawings.Both samples of debris were consistent with a corrosion product, biological material, and oxide, and hip stem base material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: not performed as no medical records were provided.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: damage was observed on the stem neck and trunnion consistent with loss of taper lock.Biological material was observed on anterior, posterior, and superior surfaces.Damage consistent with the explantation process was observed on the inferior and superior surfaces.Debris was observed on the superior surface of the neck.Nothing noteworthy was observed on the screw; x-ray fluorescence spectroscopy (xrf) was performed to confirm the material.The mar concluded: damage was observed on the stem neck and trunnion consistent with the loss of taper lock.The damage present on the articulating surface of the insert is consistent with burnishing, scratching and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration on the liner is consistent with absorption of synovial fluid.Elemental analysis showed that all metallic components were consistent with their respective drawings.Both samples of debris were consistent with a corrosion product, biological material, and oxide, and hip stem base material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 21MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-221
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8731816
• Report Number: 0002249697-2019-02373
• Device Sequence Number: 2522700
• Product Code: LPH
• UDI-Device Identifier: 04546540641212
• UDI-Public: 04546540641212
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 6276-1-221
• Device Lot Number: 25968401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR