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

Catalog Number	2101-0200
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
After the case, it was noticed that the cup impactor was stripped.No further information will be available.
Event or Problem Description
After the case, it was noticed that the cup impactor was stripped.No further information will be available.
Additional Manufacturer Narrative
An event regarding thread damage involving a cutting edge impactor was reported.The event was confirmed.Method & results: -device evaluation and results: debris was observed at the base of the threads.Thread damage was observed in addition to a thread fracture that occurred in shear overload.Elemental analysis showed the chemical composition of the debris found on the threads was consistent with an oxide, galling, the base material, the decontamination process and an unknown material.The chemical composition of the collected debris from the base of the threads was consistent with a biological material, oxide, and an unknown material.The chemical composition of the base material was consistent with a 17-4 stainless steel alloy.Hardness was performed on the threads in accordance with astm e18.The hardness was observed to be approximately 43.5 hrc, meeting the drawing requirement of 40 hrc minimum.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-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: debris was observed at the base of the threads.Thread damage was observed in addition to a thread fracture that occurred in shear overload.Elemental analysis showed the chemical composition of the debris found on the threads was consistent with an oxide, galling, the base material, the decontamination process and an unknown material.The chemical composition of the collected debris from the base of the threads was consistent with a biological material, oxide, and an unknown material.The chemical composition of the base material was consistent with a 17-4 stainless steel alloy.Hardness was performed on the threads in accordance with astm e18.The hardness was observed to be approximately 43.5 hrc, meeting the drawing requirement of 40 hrc minimum.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: 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: 9244164
• Report Number: 0002249697-2019-03618
• Device Sequence Number: 1878825
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 12/26/2019

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 2101-0200
• Device Lot Number: 135316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/26/2019
• 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: Other