MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH MULLER STEM; HIP PROSTHESIS

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Medical products: allofit cup hip impl win gen; catalog#: unknown; lot#: unknown.Therapy date: unknown.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 by the (b)(6) register (lroi) that a number of patients underwent revision surgery due to loosening, dislocation, infection, wear, peri-prosthetic fracture, girdlestone situation, peri-articular ossification and other reasons.

Manufacturer Narrative

Investigation results were made available.Review of event description: it was reported by the dutch register (lroi) that a number of patients underwent revision surgery due to loosening, dislocation, infection, wear, peri-prosthetic fracture, girdlestone situation, peri-articular ossification and other reasons.Review of received data: due diligence: no further information available, as affected hospitals are no known.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Dhr review: the dhr check could not be performed as the lot number was not available.Ie/capa/hhe(d) search: data analysis performed in response to the request from lroi did not identify any issues requiring further action and concluded that the data supports the continued use of respective systems.The overall residual risk of the devices is considered acceptable according to the risk management files.The post market surveillance reviews do not indicate any requirement for further action based on the existing clinical data.In summary, no further action is required at this time.Ongoing monitoring of the products in scope will continue to be performed.Conclusion: it was reported by the dutch register (lroi) that a number of patients underwent revision surgery due to loosening, dislocation, infection, wear, peri-prosthetic fracture, girdlestone situation, peri-articular ossification and other reasons.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

No event update.Investigation results are now available.

• Brand Name: MULLER STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11684082
• MDR Text Key: 245979261
• Report Number: 0009613350-2021-00172
• Device Sequence Number: 1
• Product Code: KWY
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention