MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

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

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 07/24/2012

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Report source is a literature article.There is limited information regarding the reported death.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).

Event Description

"literature article entitled, ¿a minimal-incision technique in total hip arthroplasty does not improve early postoperative outcomes¿ by luke ogonda, mrcs, et al, published by the journal of bone and joint surgery (2005), vol.87-a, no.4, pp.701-710, was reviewed.The objective of this study was to compare the results of a single mini-incision approach with those of a standard-incision total hip arthroplasty in the early postoperative period in 219 hips between december 2003 and june 2004.Implanted depuy products: all patients underwent a hybrid tha which included a cementless pinnacle cup and either an xpress rapid custom or c-stem cemented cup.The manufacturer of the cement is unknown.The authors do not provide information regarding the acetabular liner or femoral head.The femoral head and acetabular liner are assumed to be depuy products.Results: there were no recorded revisions during the follow-up period.1 intraoperative acetabular fracture- no treatment required and no postoperative patient consequences.1 intraoperative femoral fracture- no treatment required and no postoperative patient consequences.5 cases of postoperative hypotension that required medical intervention and postponed the patient¿s ability to comply with physiotherapy protocol.1 case of acute renal insufficiency that postponed the patient¿s ability to comply with physiotherapy protocol.The condition resolved with medical intervention that did not require dialysis.2 cases of severe postoperative nausea that required medical intervention.11 mispositioned femoral stems- no treatment required.1 deep infection treated with irrigation and debridement and 6 weeks of iv antibiotics.1 superficial wound infection treated with antibiotics.2 early dislocations treated with closed reductions.1 deep vein thrombosis- treatment unknown.1 postoperative death due to acute myocardial infarction.This patient had preexisting ischemic heart disease and a history of angioplasty.The authors do not attribute this death to the surgical procedure or the implanted tha.This death will not be included in the complaint.1 death due to extensive bowel infarction due to mesenteric vessel thrombosis.There is insufficient information provided to conclusively determine the cause of the postoperative mesenteric thrombosis.Therefore, this death is included in this complaint.Captured in this complaint: pinnacle cup, head, liner, and stem for death.Pinnacle cup: no reported product problem.Acetabular liner: implant dislocation.Femoral head: implant dislocation.Femoral stem: implant misposition.Patient harms: blood pressure abnormal, nausea, infection, wound infection, surgical intervention, joint dislocation, deep vein thrombosis, bowel infarction, thrombosis.There is insufficient information provided to attribute the renal insufficiency to the implanted products or the surgical procedure.The femoral and acetabular fracture required no intraoperative intervention and caused no postoperative patient consequences.".

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9412039
• MDR Text Key: 169118755
• Report Number: 1818910-2019-120254
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death