MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-03-52D
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
After the device was opened the surgeon noticed an unusual mark inside the shell and wasn't happy to use this for the procedure.Another implant was opened with no issues and the case was completed as planned.Surgical delay: 30 seconds to retrieve a replacement.
Additional Manufacturer Narrative
An event regarding foreign matter involving a trident shell was reported.The event was confirmed.Method & results: device evaluation and results: the inner blister tray, square pad, the plug, and the implant were returned and appears unused & intact.A scratch was found on the distal part of the implant.A material analysis was performed and concluded "foreign material was observed on the distal surface of the shell.Ftir analysis determined the assayed spectrum of the foreign material could not be matched to the available library spectrum.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 or x-rays were made available for evaluation.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 has been no other event for the lot referenced.Conclusions: the reported event for the foreign matter was confirmed based on the visual inspection of the returned implant.A material analysis was performed and concluded "foreign material was observed on the distal surface of the shell.Ftir analysis determined the assayed spectrum of the foreign material could not be matched to the available library spectrum.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." a root cause could not be determined based on the consultation with packaging sme indicating that the mar test result was found to be inconclusive and nothing in the packaging process will create this issue.No further investigation is needed at this time.If additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
After the device was opened the surgeon noticed an unusual mark inside the shell and wasn¿t happy to use this for the procedure.Another implant was opened with no issues and the case was completed as planned.Surgical delay: 30 seconds to retrieve a replacement.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 52MM
• 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: 8073792
• Report Number: 0002249697-2018-03736
• Device Sequence Number: 19265699
• Product Code: LPH
• UDI-Device Identifier: 07613327040043
• UDI-Public: 07613327040043
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K081171
• 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): 03/19/2019

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: 04/30/2023
• Device Catalogue Number: 500-03-52D
• Device Lot Number: 8W8APL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 03/19/2019
• 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