MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION GAP II ACET SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	2082-0052L
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
The pharmacist reported that: "in a (b)(6) year-old patient (female) with left hip in a context of breast neoplasia on bone radiology, first implantation of a total prosthesis on (b)(6) 2019 of left hip cemented with the insertion of a ring of reinforcement and an acetabulum with a double mobility cup (and 1 insert pe liberty, atf brand (not stryker) reference (b)(4), serial number (b)(4)).Appearance of pain in early 2020.Balance sheets imaging studies (x-ray and ct scan) reveal a the tilts of the acetabulum and particularly of the acetabular ring support.Diagnosis of aseptic implant loosening acetabular with indication for revision surgery.Revision surgery the (b)(6) 2020.At the time of the operation the surgeon found a large inflammatory granuloma, as well as a loosening of the acetabular prosthesis, on a very sclerotic radius bone.Re-cementing of an acetabular cup prosthesis in a support ring (1 left cup frame) t56 part no.2082-0056l stryker company, 1 cup double mobility liberty, atf brand (not stryker) to be cemented reference (b)(4), 1 insert liberty reference (b)(4) company atf).The devices were not kept for expertise.".
Additional Manufacturer Narrative
Reported event an event regarding loosening involving a restoration modular shell was reported.The event was confirmed via medical review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: the event was confirmed, revision and failure of acetabular reconstruction.Date of the original surgery are not consistent (b)(6) 2020 vs (b)(6) 2019.This does not appear to be an implant related issue.The root cause appears to be underlying necrotic bone and poor mechanical reconstruction construct.-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: a review of the provided medical records by a clinical consultant stated the following comment: the event was confirmed, revision and failure of acetabular reconstruction.Date of the original surgery are not consistent (b)(6) 2020 vs (b)(6) 2019.This does not appear to be an implant related issue.The root cause appears to be underlying necrotic bone and poor mechanical reconstruction construct.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
Event or Problem Description
The pharmacist reported that : "in a 49-year-old patient (female) with left hip in a context of breast neoplasia on bone radiology, first implantation of a total prosthesis on (b)(6) 2019 of left hip cemented with the insertion of a ring of reinforcement and an acetabulum with a double mobility cup (and 1 insert pe liberty, atf brand (not stryker) reference 43022246, serial number (b)(6)).Appearance of pain in early 2020.Balance sheets imaging studies (x-ray and ct scan) reveal a the tilts of the acetabulum and particularly of the acetabular ring support.Diagnosis of aseptic implant loosening acetabular with indication for revision surgery.Revision surgery the (b)(6) 2020.At the time of the operation the surgeon found a large inflammatory granuloma, as well as a loosening of the acetabular prosthesis, on a very sclerotic radius bone.Re-cementing of an acetabular cup prosthesis in a support ring (1 left cup frame) t56 part no.2082-0056l stryker company, 1 cup double mobility liberty, atf brand (not stryker) to be cemented reference 43100148, 1 insert liberty reference 43022848 company atf).The devices were not kept for expertise.".

• Brand Name: RESTORATION GAP II ACET SHELL
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10481437
• Report Number: 0002249697-2020-01784
• Device Sequence Number: 2779449
• Product Code: LZO
• UDI-Device Identifier: 07613327017540
• UDI-Public: 07613327017540
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K980774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 10/31/2023
• Device Model Number: 2082-0052L
• Device Catalogue Number: 2082-0052L
• Device Lot Number: 00051752D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: 49 YR
• Patient Weight: 57