MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED, 19/225, TAPER 12/14; WAGNER SL REVISION STEM LATERAL

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problems High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item# 00-8775-028-01, lot# 2907334, biolox delta, ceramic femoral head, s, 28/-3.5, taper 12/14.Item# 01.00102.219, lot# 2937791, wagner sl revision hip stem, uncemented, 19/225, taper 12/14.Item# 110010244, lot# 6362614, g7 osseoti 3 hole shell 52mm e 2mm e.Item# 110024463, lot# 772480, g7 dual mobility liner 42mm e.Item# xl200148, lot# 140080, act artic hd arcom xl 28x42mm.The device will not be returned for analysis as they remain implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The study report was received and will be reviewed as part of ongoing investigation.Device history record (dhr) was reviewed and no discrepancies were found.Note: this is a split case with zimmer inc., warsaw reference number (b)(4).The following reports are associated with this event: 0009613350 -2019 -00270.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that patient was diagnosed and treated for nstemi approximately 3 days postoperative, which delayed the patients discharge.Approximately 2 weeks post discharge, patient experienced an isolated episode of hypertension that required an emergency room visit.Patient was treated and released.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: pain, cardiac symptoms.Event description: it was reported that the patient was implanted with a total hip prosthesis on (b)(6) 2019.Subsequently the patient was diagnosed and treated for nstemi postoperative, which delayed the patients discharge.On 04 feb 2019 the patient experienced an isolated episode of hypertension that required an emergency room visit.Patient was treated and released.Review of received data: medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp).Findings: revision d/t failed tha; preop extreme pain, 8 on 010; spinal/epidural anesthesia; revised, head, stem, bearing; no complications during procedure.Delay in discharge due to experienced abdominal and chest burning/bruising sensation that did not resolve with gerd medication.Cardiology consult diagnosis of nstemi given aspirin and statin, metoprolol to prevent reinfarction.Discharged (b)(6) 2019.Discharged to inpatient skilled nursing facility.Returned to emergency room on (b)(6) 2019 due to episode of hypertension, blood pressure 205/88, this decreased spontaneously to 162/80.It is reported that this could have been related to pain response, discharged with instructions to monitor b/p.Patient history: patient had a known history of hypertonia.Study protocol: in the 6 weeks follow up visit dated (b)(6) 2019 patient reports extreme pain and discomfort.The pain score is 7 (from 10).Severe pain would be in the trochanter and lateral thigh.Moderate pain would be in the groin, anterior thigh and buttock.Slight pain would be in the posterior and medial thigh.Pain would occur at all times and patient takes daily pain medications.Adverse event report dated (b)(6) 2019: cardiology diagnosed a nemsti.Definitely not device related.Likely related to procedure.Adverse event report dated (b)(6) 2019: hypertension.Definitely not device related.Unlikely related to procedure.Device analysis: no product was returned to zimmer biomet for in-depth analysis as they remained implanted.Review of product documentation: all involved devices are intended for treatment.Conclusion: it was reported that the patient was implanted with a total hip prosthesis on 09 jan 2019.Subsequently the patient was diagnosed and treated for nstemi postoperative, which delayed the patients discharge.On 04 feb 2019 the patient experienced an isolated episode of hypertension that required an emergency room visit.In the study documents the adverse events are described as definitely not device related.The nemsti is likely to be related to procedure.It needs to be considered that the patient has a history of hypertonia.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).Most likely, the reported event is not product but patient or procedure related.However, based on the available information, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Please refer to report 0009613350-2019-00271.

• Brand Name: WAGNER SL REVISION HIP STEM, UNCEMENTED, 19/225, TAPER 12/14
• Type of Device: WAGNER SL REVISION STEM LATERAL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8554997
• MDR Text Key: 143239352
• Report Number: 0009613350-2019-00271
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024485242
• UDI-Public: 00889024485242
• Combination Product (y/n): N
• PMA/PMN Number: K043356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00102.219
• Device Lot Number: 2937791
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR