MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL HEAD HIP IMPL WIN

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Toxicity (2333)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

X-rays and surgical report were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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

Patient was implanted on the left side and underwent revision due to elevated metal ions levels.

Event Description

No change to previously reported event.

Manufacturer Narrative

Event description: it was reported that the patient was implanted with a metasul head and liner on (b)(6) 2008 and underwent revision on (b)(6) 2020 due to elevated metal ion levels.Review of received data: x-rays: two undated views of the left hip have been received and reviewed by hcp.Assessment of imaging: two views of the left hip demonstrate a left total hip arthroplasty with cement fixation of the acetabular cup.No evidence for polyethylene wear.Femoral component is intact.One proximal femoral cerclage wire is present.No bony fractures.Impressions: left total hip arthroplasty with no hardware failure or loosening.Overall fit and alignment of the implant is appropriate.Acetabular inclination angles cannot be accurately measured without a true ap pelvis film.However, visually, the acetabular cup appears to be in appropriate position.No evidence for loosening or subsidence or definite evidence of metal particle release.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Conclusion: it was reported that the patient revised due to elevated metal ion levels after an in-vivo time of 12 years.Based on the received undated x-rays the reported event cannot be confirmed.Neither medical records such as surgical reports, lab reports nor the complained devices have been received.The nature of the metal ions remain unknown.The reference and lot number of the complained device is unknown, therefore, manufacturing records could not be reviewed.A detailed investigation could not be performed, nevertheless based on the given information there is no indication of a non-conformance or complaint out of box (coob).Based on the significant lack of information we were neither able to confirm the reported event nor to perform an in-depth investigation on the reported event.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).The following reports are associated with this event: 0009613350-2020-00244, 0009613350-2020-00249.

• Brand Name: METASUL HEAD HIP IMPL WIN
• Type of Device: METASUL HEAD HIP IMPL WIN
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10137654
• MDR Text Key: 194642581
• Report Number: 0009613350-2020-00249
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR