MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ9 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-165

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After a review of the medical record, the patient was revised to address painful left metal-on-metal total hip arthroplasty with elevated metal ions.Patient alleges pain with range of motion and in the knee, severe sudden pain that makes difficult to walk, and elevated metal ions.Operative notes indicated that upon opening up the fascia, black stained tissue was seen translucently through thin tissue.Bulbous cystic tissue was noted when flaps were created.7 ml of clear fluid was removed from the joint.The entire cystic structure was taken down off the bone with bleeding points were coagulated on the inside showed both whitish devitalized tissue and some mildly blackish stained gray stained tissue.The capsule appeared fibrotic.A rongeur was used to remove other small areas of metal stained tissue about the posterior tissues.Any metal stained tissue was debrided.The fibrotic anterior tissue was evaluated.It was felt that some of this represented capsular tissue.This tissue was then tensed and attempt made to remove the underlying metal stained debris about the anterior capsule.The modular head was now disimpacted from the trunnion which showed minimal metal staining.The femur was held, significant rotational pressure applied to the femur and there was no obvious motion.Dissection was performed removing any thickened fibrotic tissue anteriorly and inferiorly until full exposure was obtained around the acetabulum.What was felt to be possible osteophyte was removed anteroinferiorly as well.Significant tissue posterior to the liner was seen of yellowish nature and was obtained.The acetabulum was then cleaned and debrided of additional yellow tissue.A single screw was seen and was backed out two-thirds of the way.Significant pressure was then applied outward about the lateral border of the acetabulum and there was no obvious motion.Doi: (b)(6) 2005 - dor: (b)(6) 2019 (left hip).Please see (b)(4) for the second revision.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ9 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9929192
• MDR Text Key: 189635048
• Report Number: 1818910-2020-10256
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060109
• UDI-Public: 10603295060109
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 1570-11-165
• Device Catalogue Number: 157011165
• Device Lot Number: Y4LFT1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR