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

Model Number	6276-1-221
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that during revision of restoration modular proximal body, the head and trunnion exhibited trunnionosis.
Additional Manufacturer Narrative
Additional information: update to lot number.An event regarding wear involving a restoration modular body was reported.The event was confirmed.Method & results: device evaluation and results: damage was observed on the neck of the stem consistent with the explantation process.Damage consistent with interaction of the head against the stem trunnion was observed.Debris was observed on the inner taper of the head.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the acetabular component is in nominal position and has 2 screws in situ.The hip is reduced.Based upon the minimal information available, no confirmation of the event description is possible nor is creating a report possible for this case.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: damage on the taper of the head was consistent with fretting.Debris on the inner taper was consistent with an oxide, a corrosion product, biological material and material transfer from the stem.Eds showed that each component was consistent with their respective drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
It was reported that during revision of restoration modular proximal body, the head and trunnion exhibited trunnionosis.

• 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: 9512723
• Report Number: 0002249697-2019-04082
• Device Sequence Number: 18929560
• Product Code: LPH
• UDI-Device Identifier: 04546540641212
• UDI-Public: 04546540641212
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

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: 09/30/2020
• Device Model Number: 6276-1-221
• Device Catalogue Number: 6276-1-221
• Device Lot Number: 52635205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 05/06/2020
• 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