MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 20MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	7030-6520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: 6.5mm low profile hex screw 20mm; 7030-6520 ; lot # yue.6.5mm low profile hex screw 15mm; 7030-6515 ; lot# unknown.6.5mm low profile hex screw 15mm; 7030-6515 ; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's left hip was revised.Two days post op, a large hematoma had formed and suspected to be over a nerve as the patient was experiencing foot weakness.Two 20mm screws, two 15mm screws, an mdm metal liner, adm/ mdm poly insert, and 28 +4 head were revised.The 20mm screws were replaced with two additional 15mm screws, and the mdm metal liner, adm/ mdm poly insert, and femoral head were re-implanted.Rep confirmed there are no allegations against the revised and re-implanted metal liner, poly insert, or femoral head.Rep provided the primary usage sheet and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 20MM
• 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: 12460651
• Report Number: 0002249697-2021-01550
• Device Sequence Number: 19814389
• Product Code: LPH
• UDI-Device Identifier: 07613327345094
• UDI-Public: 07613327345094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 03/31/2026
• Device Model Number: 7030-6520
• Device Catalogue Number: 7030-6520
• Device Lot Number: Z28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/13/2021
• 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: 62 YR
• Patient Weight: 91