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); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other events for the lot referenced.
Event or Problem Description
Our company representative reported that" the groove portion of the product is broken.The problem of the product was noticed after the patient was applied.".
Event or Problem Description
Our company representative reported that" the groove portion of the product is broken.The problem of the product was noticed after the patient was applied.".
Additional Manufacturer Narrative
An event regarding thread damage involving a cutting edge impactor was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: examination of the returned device with engineer indicated damage observed on the threads consistent with contact against hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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: examination of the returned device with engineer indicated damage observed on the threads consistent with contact against hard object.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.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.After review of the inv conclusion, the reported hazard and risk assessment was updated and this event was deemed not reportable as per the following: a review of the peripheral legacy instruments risk table, a0000880 ver.5, for any hazard resulting in extended surgery time indicates that the highest potential severity of harm is s3 with a potential occurrence level o1.Additionally, a review of the complaint history data for the past four years indicated there have been no reports of serious injury or death as a result of similar events with this device family.Based upon this review, it is unlikely that a serious injury or death would result if this event were to recur.Therefore, this event is not reportable.

• 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: 9702561
• Report Number: 0002249697-2020-00279
• Device Sequence Number: 1742594
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2101-0200
• Device Catalogue Number: 2101-0200
• Device Lot Number: 144495
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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