MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-60F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: delta v-40 ceramic head 36/0; 6570-0-136 ; 61350701.Trident 10° x3 insert 36mm id; 623-10-36f ; j307ey.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding pain involving a trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided for a review to the consulting clinician which noted," a revision event x2 may be confirmed, but the sides were not provided for the implant logs and no op notes to confirm the events themselves.No root cause can be ascribed to the cases as there were no medical records, x-rays or other materials to assess".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: it was reported that the patient's hip was revised due to pain.The available medical records were provided for a review to the consulting clinician which noted that a revision event x2 may be confirmed, but the sides were not provided for the implant logs and no op notes to confirm the events themselves.No root cause can be ascribed to the cases as there were no medical records, x-rays or other materials to assess.The event could not be confirmed nor the root cause be determined because insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
It was reported that the patient's left hip was revised due to pain.A shell and head implanted (b)(6) 2018 and a liner implanted (b)(6) 2019 were revised to a shell with 4 screws, mdm metal liner, adm/ mdm insert, and ceramic head with sleeve were implanted.Rep provided implant information for all surgeries and the primary operative report, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM
• 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: 11677498
• Report Number: 0002249697-2021-00692
• Device Sequence Number: 17022075
• Product Code: LPH
• UDI-Device Identifier: 07613327040173
• UDI-Public: 07613327040173
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 502-03-60F
• Device Catalogue Number: 502-03-60F
• Device Lot Number: NV447J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/16/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR