MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-48C
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.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.
Event or Problem Description
The surgeon stated that tritanium loosened.The patient was a (b)(6) year-old female patient (160 cm in height and (b)(6) kg in weight).Update: "the stem was not loose, but since the cup operation becomes difficult, the surgeon also pulls out the stem in case of cup replacement even if it is not loose." right side.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: the shell, liner, ceramic head, two screws and stem were returned for evaluation.The device were decontaminated before evaluation.There are scratches marks on the device, which is an evidence that the device was an used implant.Nothing else remarkable to report.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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.
Event or Problem Description
The surgeon stated that tritanium loosened.The patient was a 53-year-old female patient (160 cm in height and 53 kg in weight).Update: "the stem was not loose, but since the cup operation becomes difficult, the surgeon also pulls out the stem in case of cup replacement even if it is not loose." right side.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 48MM
• 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: 10507797
• Report Number: 0002249697-2020-01819
• Device Sequence Number: 11080245
• Product Code: LPH
• UDI-Device Identifier: 07613327040111
• UDI-Public: 07613327040111
• Combination Product (Y/N): N
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 10/31/2020
• Device Model Number: 502-03-48C
• Device Catalogue Number: 502-03-48C
• Device Lot Number: TR6M11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: Hospitalization; Required Intervention
• Patient Weight: 53