MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM. CUP W/HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 1236-2-856

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

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 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.Catalog numbers and lot codes of other devices listed in this report: 1235-2-561 restoration (tm) adm.Cup w/ha lot: g2977192, 6570-0-328, delta v-40 ceramic head 28/-2,7, lot: 43160501, 6021-0335, accolade plus tmzf hip stem #3, lot: 42796403.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

The following was reported: total hip replacement on (b)(6) 2013 then subject reports pain at operative site in on (b)(6) 2022.Diagnosed with trochanteric bursitis and treated with local infiltration bucaine and lipotalone.The bursitis is considered related to the surgical procedure.

Event Description

The following was reported: total hip replacement on 04 jun 2013 then subject reports pain at operative site in aug 2022.Diagnosed with trochanteric bursitis and treated with local infiltration bucaine and lipotalone.The bursitis is considered related to the surgical procedure.Update medical review: {.}a tha was performed on the right side for oa.The implants were an accolade tmzf stem and an adm cup.The stem was either placed a bit deep in the canal or subsided at some point to a stable position and remained there through the entire series of x-rays.The right limb was perhaps slightly short with some decreased offset compared to the left.The cup was quite vertical but seemed to be stable mechanically stable.Of note, none of the x-rays were dated or labelled so the time and sequence could not be determined.

Manufacturer Narrative

Correction: reportable device updated based on inv conclusion.D1 - d4, g4 and h4 have been corrected.An event regarding malposition involving an adm shell was reported.The event was confirmed through medical review of the provided documents.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: 'narrative: little medical history, pre or postop course were presented for review.No data on the symptoms or care plan for the complaints outlined in the pi report were provided for review.The patient had a tha on the left with an unknown component.The stem was in varus and there was a large collar on the head.The stem and cup were otherwise stable and seemed to remain so through the review.A tha was performed on the right side for oa.The implants were an accolade tmzf stem and an adm cup.The stem was either placed a bit deep in the canal or subsided at some point to a stable position and remained there through the entire series of x-rays.The right limb was perhaps slightly short with some decreased offset compared to the left.The cup was quite vertical but seemed to be mechanically stable.Of note, none of the x-rays were dated or labelled so the time and sequence could not be determined.Conclusion/assessment: no real conclusions can be made other than there a right hip was implanted and was either placed deep in the canal or subsided to a stable position.There was perhaps slight shortening and decreased offset compared to the left side.The implants appeared otherwise stable.No conclusions can be made relative to the complaints in the pi report.Event confirmation: the placement of an accolade tmzf stem and adm cup may be confirmed.The outcome and complaints in the pi report cannot be confirmed without additional medical information.Root cause: a root cause of the complaint cannot be ascertained.' -device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the event was confirmed through medical review of the provided documents.As per the clinician review 'the outcome and complaints in the pi report cannot be confirmed without additional medical information.' no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: cat# 1236-2-856; restoration adm x3 ins 28/56; lot# 38447601.Cat# 6570-0-328; delta v-40 ceramic head 28/-2,7; lot# 43160501.Cat# 6021-0335; accolade plus tmzf hip stem #3 6021-0335; lot# 42796403.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: RESTORATION (TM) ADM. CUP W/HA
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: joann ripoli ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15957033
• MDR Text Key: 305241923
• Report Number: 0002249697-2022-01797
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638786
• UDI-Public: 04546540638786
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: 1236-2-856
• Device Catalogue Number: 1235-2-561
• Device Lot Number: G2977192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 98 KG