MAUDE Adverse Event Report: ZIMMER GMBH B-S REINFORCEMENT CAGE HIP IMPLANT; HIP PROSTHESIS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

It was discovered that the legal manufacturer of the reported product is zimmer (b)(4).The initial report was submitted under mfr report number 0001822565-2016-04449 by zimmer inc., (b)(4).All available information is covered in the report at hand.As the case at hand was taken from a journal article it is not suspected that the device or additional information is being submitted for review.A technical investigation was not possible to perform, as the devices were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.Device history records (dhr) review results: as no lot numbers were provided for the devices, the device history records could not be reviewed.An e-mail requesting missing device data information was sent on december 16, 2016.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Trend analysis: a trend analysis could not be performed as no item number was available.Event summary: it was reported that patient 13 experienced radiolucency and lateral migration, 2.9 mm at 5 years.Aaos score was iii, paprosky score 2c and harris hip score 53,56,471,2 5 years respectively.Review of received data no medical data such as x-rays, surgical notes or any other case-relevant documents received devices analysis no product was returned to zimmer biomet for in-depth analysis.Review of product documentation no product documentation was reviewed for investigation.Root cause determination using dfmea - aseptic loosening, migration of implant due to insufficient secondary stability due to surface structure.- not possible, a systematic issue with design and/or material properties would have been detected as part of complaint trending defined in complaint registration or in the current pms process post market surveillance.- impingement with stem (decreased rom), dislocation, subluxation,migration of implant,stress shielding due to malpositioning of the implant, wrong alignment.- possible, as no x-rays were provided.- migration of implant due to wrong selection of component sizes, planning, operation technique and use of instruments.- possible as no x-rays were provided.Conclusion summary neither x-rays, operative notes, nor office visit notes were received for a deep assessment.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), relevant medical history and adherence to rehabilitation protocol are unknown.Due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Based on the information available for the investigation, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

Event Description

It was reported in a journal article, that a patient experienced radiolucency and lateral migration, 2.9 mm at 5 years.Aaos score was iii, paprosky score 2c and harris hip score 53,56,47 at 1,2 5 years respectively.(a.J.Van koeveringe, p.E.Ochsner: revision cup arthroplasty using burch-schneider anti-protrusio cage.In: international orthopaedics (2002) 26:291-295.).

• Brand Name: B-S REINFORCEMENT CAGE HIP IMPLANT
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6266002
• MDR Text Key: 65354081
• Report Number: 0009613350-2017-00083
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 01/20/2017
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR