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

Model Number	1440-2011
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Primary procedure, right hip.It was reported that the impactor bolt became cross-threaded when it was inserted into the cup.Surgeon confirmed there are no allegations against the impactor bolt or the shell.The shell was implanted using a new bolt.The procedure was completed successfully with no surgical delay.
Additional Manufacturer Narrative
An event regarding a thread damage during involving an impactor bolt was reported.The event was confirmed based on evaluation of the returned devices.Method & results: device evaluation and results: visual inspection of the returned device noted that the device was returned in used condition.Damage was observed on the male threads.Examination of the returned device by a material analysis engineer noted that damage consistent with cross threading was observed on the male threads of the impactor bolt.X-ray florescence spectroscopy were was performed on the bolt and the analysis showed that the device was consistent with the drawing (17-4 ph).Hardness testing was performed per (b)(4) on the threaded stud of the bolt which had a hardness of 47hrc meeting the drawing requirement of 40hrc minimum.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional and functional analysis were not performed as the device was returned in damaged condition.Clinician review: no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.  complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the impactor bolt became cross-threaded when it was inserted into the cup.Surgeon confirmed there are no allegations against the impactor bolt or the shell.Examination of the returned device by a material analysis engineer noted that damage consistent with cross threading was observed on the male threads of the impactor bolt.X-ray florescence spectroscopy were was performed on the bolt and the analysis showed that the device was consistent with the drawing (17-4 ph).Hardness testing was performed per (b)(4) on the threaded stud of the bolt which had a hardness of 47hrc meeting the drawing requirement of 40hrc minimum.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is possible at this time.If further information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, right hip.It was reported that the impactor bolt became cross-threaded when it was inserted into the cup.Surgeon confirmed there are no allegations against the impactor bolt or the shell.The shell was implanted using a new bolt.The procedure was completed successfully with no surgical delay.

• Brand Name: CUP IMPACTOR BOLT
• 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: 9537183
• Report Number: 0002249697-2020-00007
• Device Sequence Number: 546579
• Product Code: LPH
• UDI-Device Identifier: 07613327196245
• UDI-Public: 07613327196245
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 1440-2011
• Device Catalogue Number: 1440-2011
• Device Lot Number: ERDAH0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 01/01/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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: 49 YR