MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	1236-2-244
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	01/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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.Device not returned.
Event or Problem Description
This pi is for patient's revision on (b)(6) 2019.Patient had primary total right hip arthroplasty (b)(6) 2016.Doctor performed hip revision on (b)(6) 2018 [pi (b)(6)] and converted to mdm construct.Doctor said patient was bending down to feed dogs and felt pop in her hip.X-ray showed patient's hip dislocated.Closed reduction performed.Doctor decided to perform second revision and upon exposure found stem well fixed and aligned, the 22.2mm head well fixed to the stem but disassociated from the adm x3 poly, and the poly loose from the mdm liner.The liner was well fixed to the cup and the cup was well fixed and well aligned.Doctor stated that the disassociation could have happened either prior to the closed reduction or during the closed reduction.He then proceeded to remove 22.2 femoral head with bone tamp and mallet and mdm liner from cup using a osteotome and mallet.Doctor implanted a trident 0° constrained acetabular insert size d and 22.2 x 0 v40 femoral head.Patient had a spinal fusion prior to initial surgery.
Additional Manufacturer Narrative
Corrected data: it was discovered that the selection for b2 was inadvertently missed during the submission of the initial report.B2 has been updated with the appropriate information.
Event or Problem Description
This pi is for patient's revision on (b)(6) 2019.Patient had primary total right hip arthroplasty (b)(6) 2016.Doctor performed hip revision on (b)(6) 2018 [pi (b)(6)] and converted to mdm construct.Doctor said patient was bending down to feed dogs and felt pop in her hip.X-ray showed patient's hip dislocated.Closed reduction performed.Doctor decided to perform second revision and upon exposure found stem well fixed and aligned, the 22.2mm head well fixed to the stem but disassociated from the adm x3 poly, and the poly loose from the mdm liner.The liner was well fixed to the cup and the cup was well fixed and well aligned.Doctor stated that the disassociation could have happened either prior to the closed reduction or during the closed reduction.He then proceeded to remove 22.2 femoral head with bone tamp and mallet and mdm liner from cup using a osteotome and mallet.Doctor implanted a trident 0° constrained acetabular insert size d and 22.2 x 0 v40 femoral head.Patient had a spinal fusion prior to initial surgery.

• Brand Name: RESTORATION ADM X3 INS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8319121
• Report Number: 0002249697-2019-00770
• Device Sequence Number: 1692377
• Product Code: JDI
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: 10/31/2022
• Device Model Number: 1236-2-244
• Device Catalogue Number: 1236-2-244
• Device Lot Number: 374153
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2019
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 11/25/2020
• 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 Age: 57 YR
• Patient Weight: 76