MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	2101-0200
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hip Fracture (2349); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional 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 no 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.
Event or Problem Description
During inserting the item it broke.The impactor has damaged the acetabulum.The procedure was successfully completed by inserting the primary trident cup as planned.
Additional Manufacturer Narrative
Patient's bone was fractured intraoperatively.Correcting b1 to adverse event and h1 to serious injury.Removed expiration date d4, n/a for reusable device patient information updated.An event regarding intraoperative fracture involving a cutting edge impactor was reported.The event was not confirmed.Method & results -product evaluation and results: visual inspection of the returned device noted the following: the impactor was returned at a used condition.There are abrasion marks on the impactor surface.Nothing else remarkable to report.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: brief translated operative report dated 11/12/19 "cementless right tha diagnosis coxarthrosis right.Anterior minimally invasive approach.Components: 54 stryker tritanium cup, 36/0 degree x-3 insert, #6 accolade ii stem, 36/-5 v-40 ceramic head.No complications or problems listed.No clinical or past medical history, no imaging studies available for review.There is no confirmation of the event description and no report is possible for this case.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that during the surgery when inserting the trial, the trial device broke and the impactor has damaged the acetabulum.The impactor was returned at a used condition.There are abrasion marks on the impactor surface.Nothing else remarkable to report.The event cannot be confirmed and the exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During inserting the item it broke.The impactor has damaged the acetabulum.The procedure was successfully completed by inserting the primary trident cup as planned.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• 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: 9444235
• Report Number: 0002249697-2019-03986
• Device Sequence Number: 3231210
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• PMA/510(K) Number: K161569
• 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): 03/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 2101-0200
• Device Catalogue Number: 2101-0200
• Device Lot Number: 144189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 03/13/2020
• 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: Other
• Patient Age: 57 YR