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

Model Number	1236-2-244
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Joint Laxity (4526)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: 6.5 cancellous bone; cat# 2030-6515-1; lot# unknown.C-taper cocr lfit head 22mm/0; cat# 06-2200; lot# unknown.Trident psl with purefix ha 46mm; cat# 542-11-46d; lot# unknown.Secur-fit max 132 hip stem #6; cat# 6051-0625s; lot# unknown.Acetabular dome hole plug; cat# 2060-0000-1; lot# unknown.Modular dual mobility insert; cat# 626-00-38d; lot# unknown.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 instability involving an adm liner was reported.The event was not confirmed.Method & results: device evaluation and results:.Material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary, an undated surgical implant record, an x-ray report dated (b)(6) 2021, an mri report dated (b)(6) 2021, an x-ray report dated (b)(6) 2021, an ap pelvis x-ray dated (b)(6) 2021, and operative report dated (b)(6) 2017.The event description from the product inquiry summaries states: patient states she is experiencing instability of her left hip.Primary posterior left hip surgery performed on (b)(6) 2017 and patient has had instability issues since surgery.{patient is scheduled for a left hip revision on (b)(6) 2023.She experienced a fall in 2021 and tore her left hamstring and experienced mild edema however a dislocation was ruled out via x-ray.Patient inquiring if products are for recall.The primary operative report describes an uncomplicated left tha.The three x-ray reports describe the hip to be without mechanical complication or loosening.The mri describes a partial thickness hamstring tear.The ap pelvis x-ray shows a cemented stem and pressfit acetabulum.The acetabulum appears to be in expected position.The stem is in varus.No objective documentation was proved to confirm instability or dislocation.Instability of a primary left tha cannot be confirmed.Should additional information become available i would be happy to further this assessment.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to pi including the product inquiry summary, an undated surgical implant record, an x-ray report dated (b)(6) 2021, an mri report dated (b)(6) 2021, an x-ray report dated (b)(6) 2021, an ap pelvis x-ray dated (b)(6) 2021, and operative report dated (b)(6) 2017.The event description from the product inquiry summaries states: patient states she is experiencing instability of her left hip.Primary posterior left hip surgery performed on (b)(6) 2017 and patient has had instability issues since surgery.{patient is scheduled for a left hip revision on (b)(6) 2023.She experienced a fall in 2021 and tore her left hamstring and experienced mild edema however a dislocation was ruled out via x-ray.Patient inquiring if products are for recall.The primary operative report describes an uncomplicated left tha.The three x-ray reports describe the hip to be without mechanical complication or loosening.The mri describes a partial thickness hamstring tear.The ap pelvis x-ray shows a cemented stem and pressfit acetabulum.The acetabulum appears to be in expected position.The stem is in varus.No objective documentation was proved to confirm instability or dislocation.Instability of a primary left tha cannot be confirmed.Should additional information become available i would be happy to further this assessment.It is also noted that the patient inquired if any of the devices are subject to a product recall.As no lot information was provided it cannot be determined is any of the reported devices are subject to a product recall.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.Device not returned.
Event or Problem Description
Patient stated she is experiencing instability with her left hip.Primary posterior left hip surgery was performed on (b)(6) 2017 and patient has had instability issues since the surgery.Patient is scheduled for a left hip revision on (b)(6) 2023.Patient stated she experienced a fall in 2021 in which she "tore" her left hamstring and experienced mild edema however a dislocation was ruled out via xray.Patient inquiring if products are subject to recall.Update: patient confirmed a left hip revision performed on (b)(6) 23."they did replace my cup, liner and ball but that¿s all i know this far.".

• Brand Name: RESTORATION ADM X3 INS
• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16758765
• Report Number: 0002249697-2023-00391
• Device Sequence Number: 19591584
• Product Code: LZO
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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 Model Number: 1236-2-244
• Device Catalogue Number: 1236-2-244
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 68 KG